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Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499353
Recruitment Status : Terminated (This study was terminated based on Pfizer's change in clinical development strategy not related to safety and efficacy.)
First Posted : April 17, 2018
Results First Posted : November 9, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Early Breast Cancer
Intervention Drug: TALAZOPARIB
Enrollment 61
Recruitment Details  
Pre-assignment Details A total of 61 participants were enrolled and treated with talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Period Title: Treatment
Started 61
Completed 45
Not Completed 16
Reason Not Completed
Adverse Event             3
Progressive Disease             10
Other             1
Withdrawal by Subject             2
Period Title: Safety Follow-up
Started 49
Received Treatment 0
Completed 49
Not Completed 0
Period Title: Long-Term Follow-up
Started 58
Received Treatment 0
Completed 0
Not Completed 58
Reason Not Completed
Death             2
Study Terminated By Sponsor             55
Withdrawal by Subject             1
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who received any amount of talazoparib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean Number Analyzed 61 participants
44.6  (12.7)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
18-44 Years
37
  60.7%
45-64 Years
18
  29.5%
>=65 Years
6
   9.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
61
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
White
47
  77.0%
Black or African American
7
  11.5%
Asian
3
   4.9%
Not reported
4
   6.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Chinese
1
   1.6%
African American
7
  11.5%
Ashkenazi Jew
1
   1.6%
Other
49
  80.3%
Not reported
3
   4.9%
Number of Participants with Triple Negative Breast Cancer (TNBC) at Baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
61
 100.0%
[1]
Measure Description: Participants with TNBC at baseline were defined as participants that lacked estrogen receptor (ER Negative), progesterone receptor (PR Negative) and human epidermal growth factor receptor 2 (HER2 Negative) at baseline.
Duration of Breast Cancer at Baseline   [1] 
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 61 participants
3.57
(0.43 to 21.14)
[1]
Measure Description: Duration (since onset) was defined as time (weeks) from histopathological (primary) diagnosis until study entry (baseline).
Number of Participants with Breast Cancer Gene 1/2 (BRCA1/2) Mutations at Baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
BRCA1
48
  78.7%
BRCA2
13
  21.3%
[1]
Measure Description: Participants with BRCA1/2 mutations at baseline were defined as participants with positive Myriad BRCA1/2 laboratory test results at baseline.
1.Primary Outcome
Title Percentage of Participants Achieving Pathological Complete Response (pCR) as Per Independent Central Review (ICR) in Evaluable Analysis Set as Per ICR With 80% Confidence Interval (CI)
Hide Description pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current American Joint Committee on Cancer [AJCC] staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 48
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: Percentage of participants
45.8
(36.42 to 55.22)
2.Primary Outcome
Title Percentage of Participants Achieving pCR as Per ICR in Evaluable Analysis Set as Per ICR With 95% CI
Hide Description pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
45.8
(31.98 to 60.62)
3.Secondary Outcome
Title Percentage of Participants Achieving pCR as Per ICR in Intention-to-Treat (ITT) Analysis Set With 80% CI
Hide Description pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: Percentage of participants
49.2
(40.97 to 57.39)
4.Secondary Outcome
Title Percentage of Participants Achieving pCR as Per ICR in ITT Analysis Set With 95% CI
Hide Description pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
49.2
(36.70 to 61.63)
5.Secondary Outcome
Title Percentage of Participants Achieving pCR as Per Investigator in Evaluable Analysis Set as Per Investigator
Hide Description pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the talazoparib dose prescribed at treatment start (1 mg/day, except participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by investigator, as well as participants who progressed or died before pCR could be assessed by investigator (these participants were considered as non-responders).
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
45.8
(31.98 to 60.62)
6.Secondary Outcome
Title Percentage of Participants Achieving pCR as Per Investigator in ITT Analysis Set
Hide Description pCR was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ie, ypT0/Tis ypN0 in the current AJCC staging system). pCR rate by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
47.5
(35.03 to 60.09)
7.Secondary Outcome
Title Percentage of Participants Achieving pCR in Breast Only as Per Investigator in Evaluable Analysis Set as Per Investigator
Hide Description pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per Investigator). The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the talazoparib dose prescribed at treatment start (1 mg/day, except participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by investigator, as well as participants who progressed or died before pCR could be assessed by investigator (these participants were considered as non-responders).
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
45.8
(31.98 to 60.62)
8.Secondary Outcome
Title Percentage of Participants Achieving pCR in Breast Only as Per Investigator in ITT Analysis Set
Hide Description pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by investigator in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by investigator review after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
47.5
(35.03 to 60.09)
9.Secondary Outcome
Title Percentage of Participants Achieving pCR in Breast Only as Per ICR in Evaluable Analysis Set as Per ICR
Hide Description pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the evaluable population (Evaluable Analysis Set as per ICR). The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
47.9
(34.11 to 62.75)
10.Secondary Outcome
Title Percentage of Participants Achieving pCR in Breast Only as Per ICR in ITT Analysis Set
Hide Description pCR in breast was defined as the absence of residual invasive cancer in the breast and axillary lymph nodes on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant therapy with talazoparib. pCR rate in breast by ICR in ITT Analysis Set was defined as the percentage of participants achieving pCR in breast by ICR after talazoparib treatment for 24 weeks, followed by surgery, among all participants in the ITT Analysis Set. The exact CI was calculated using the Blaker's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.8
(38.37 to 63.30)
11.Secondary Outcome
Title Percentage of Participants With Residual Cander Burden (RCB) as Per ICR in Evaluable Analysis Set as Per ICR
Hide Description The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the dose of talazoparib prescribed at treatment start (1 mg/day, with the exception of participants with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment by ICR, as well as participants who progressed or died before pCR could be assessed by ICR (these participants were considered as non-responders).
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
RCB - 0
45.8
(29.0 to 63.7)
RCB - I
0.0
(0.0 to 12.1)
RCB - II
31.3
(17.2 to 49.8)
RCB - III
0.0
(0.0 to 12.1)
Missing (Participants who had progressive disease or with missing required axillary specimen)
22.9
(11.2 to 41.2)
12.Secondary Outcome
Title Percentage of Participants With RCB as Per ICR in ITT Analysis Set
Hide Description The RCB is a continuous index derived from the following: primary tumor dimensions; cellularity of the tumor bed; axillary nodal burden. Residual cancer burden by ICR is reported as a categorical variable with four classes (categories): RCB 0 (pCR), I (minimal RCB), II (moderate RCB), III (extensive RCB). Participants who had progressive disease or was unable to be assessed for RCB due to missing required axillary specimen were counted in the "Missing" category. The simultaneous exact CI was calculated using Goodman's method.
Time Frame Date of surgery (maximum of approximately 8 months post-baseline) (assessed within a maximum of 6 weeks of last dose of talazoparib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
RCB - 0
49.2
(33.6 to 64.9)
RCB - I
1.6
(0.2 to 12.6)
RCB - II
27.9
(15.8 to 44.2)
RCB - III
0.0
(0.0 to 9.8)
Missing (Participants who had progressive disease or with missing required axillary specimen)
21.3
(11.0 to 37.3)
13.Secondary Outcome
Title Probability of Being Event-Free at 3 Years in Evaluable Analysis Set
Hide Description Event-Free Survival (EFS) is defined as the time from surgery date to first documentation of local or distant recurrence or death or initiation of antineoplastic therapy before documentation of first relapse. Participants discontinuing study before documentation of first relapse or death, but after surgery were censored observations for EFS. EFS at 3 years is defined as the probability of being event free at 3 years after surgery using Kaplan Meier methods.
Time Frame 3 years after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the dose prescribed at treatment start (1 mg/day, except those with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment, and participants who progressed or died before pCR could be assessed. EFS at 3 years was not analyzed as the 3-year threshold was not reached at study termination, therefore number of participants analyzed was 0.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Probability of Being Alive at 3 Years in Evaluable Analysis Set
Hide Description Overall Survival (OS) is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
Time Frame 3 years after first dose of talazoparib
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants enrolled who received at least 80% of the dose prescribed at treatment start (1 mg/day, except those with baseline moderate renal impairment who received a starting dose of 0.75 mg/day) and underwent breast surgery and pCR assessment, and participants who progressed or died before pCR could be assessed. OS at 3 years was not analyzed as the 3-year threshold was not reached at study termination, therefore number of participants analyzed was 0.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Probability of Being Alive at 3 Years in ITT Analysis Set
Hide Description OS is defined as the time from first dose of talazoparib to death due to any cause. Participants not known to have died at the time of the analysis were right censored on the date they were last known to be alive before the analysis data cutoff date. OS at 3 years is defined as the probability of being alive at 3 years after first dose of talazoparib using Kaplan Meier methods.
Time Frame 3 years after first dose of talazoparib
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib. OS at 3 years was not analyzed as no participants had yet reached the 3-year threshold when the study was terminated, therefore the number of participants analyzed for this outcome measure was 0.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or worsened relative to pretreatment state. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality TEAEs
60
  98.4%
All-causality Grade 3 or 4 TEAEs
29
  47.5%
All-causality Grade 5 TEAEs
0
   0.0%
Treatment-related TEAEs
58
  95.1%
Treatment-related Grade 3 or 4 TEAEs
27
  44.3%
Treatment-related Grade 5 TEAEs
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality SAEs
11
  18.0%
Treatment-related SAEs
9
  14.8%
18.Secondary Outcome
Title Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Drug
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality TEAEs
3
   4.9%
Treatment-related TEAEs
3
   4.9%
19.Secondary Outcome
Title Number of Participants With TEAEs Leading to Temporary Discontinuation of Study Drug
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality TEAEs
20
  32.8%
Treatment-related TEAEs
19
  31.1%
20.Secondary Outcome
Title Number of Participants With TEAEs Leading to Dose Reduction of Study Drug
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred between first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality TEAEs
24
  39.3%
Treatment-related TEAEs
24
  39.3%
21.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Laboratory parameters included hematology, serum chemistry, urinalysis and coagulation. Grades of laboratory abnormalities were defined according to NCI CTCAE version 4.03. Participants with laboratory test abnormalities meeting specified criteria (>upper limit of normal [ULN] or <lower limit of normal [LLN]) (without regards to baseline abnormality) are reported.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib. Number of participants analyzed refers to number of participants evaluable for this outcome measure. Number analyzed refers to total number of participants with at least 1 observation of the given laboratory test.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
Erythrocyte Mean Corpuscular Volume <LLN Number Analyzed 61 participants
1
   1.6%
Erythrocyte Mean Corpuscular Volume >ULN Number Analyzed 61 participants
33
  54.1%
Erythrocytes <LLN Number Analyzed 44 participants
38
  86.4%
Hematocrit <LLN Number Analyzed 61 participants
39
  63.9%
Blood urea nitrogen >ULN Number Analyzed 61 participants
3
   4.9%
Lactate dehydrogenase >ULN Number Analyzed 61 participants
8
  13.1%
Protein <LLN Number Analyzed 61 participants
5
   8.2%
Protein >ULN Number Analyzed 61 participants
2
   3.3%
Prothrombin Time <LLN Number Analyzed 35 participants
2
   5.7%
22.Secondary Outcome
Title Number of Participants With Hematology Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
Hide Description Hematology laboratory parameters included hematocrit, hemoglobin, mean corpuscular volume, red blood cells, platelets, white blood cells with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Grades of lab results were defined by NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE. This outcome measure was based only on laboratory data. As Grade 4 anemia cannot be assessed based only on laboratory data, it was not applicable for analysis in this outcome measure.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib. Number of participants analyzed refers to number of participants evaluable for this outcome measure. Number analyzed refers to total number of participants who had on-study laboratory test values that were applicable for the assessment of the laboratory results of interest.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia Grade 0 to Grade 3 Number Analyzed 61 participants
7
  11.5%
Anemia Grade 1 to Grade 3 Number Analyzed 61 participants
1
   1.6%
Anemia Grade 2 to Grade 3 Number Analyzed 61 participants
0
   0.0%
Anemia Grade 0 to Grade 4 Number Analyzed 0 participants
Anemia Grade 1 to Grade 4 Number Analyzed 0 participants
Anemia Grade 2 to Grade 4 Number Analyzed 0 participants
Lymphocyte count decreased Grade 0 to Grade 3 Number Analyzed 61 participants
1
   1.6%
Lymphocyte count decreased Grade 1 to Grade 3 Number Analyzed 61 participants
0
   0.0%
Lymphocyte count decreased Grade 2 to Grade 3 Number Analyzed 61 participants
0
   0.0%
Lymphocyte count decreased Grade 0 to Grade 4 Number Analyzed 61 participants
0
   0.0%
Lymphocyte count decreased Grade 1 to Grade 4 Number Analyzed 61 participants
0
   0.0%
Lymphocyte count decreased Grade 2 to Grade 4 Number Analyzed 61 participants
0
   0.0%
Neutrophil count decreased Grade 0 to Grade 3 Number Analyzed 61 participants
3
   4.9%
Neutrophil count decreased Grade 0 to Grade 4 Number Analyzed 61 participants
0
   0.0%
Neutrophil count decreased Grade 1 to Grade 3 Number Analyzed 61 participants
0
   0.0%
Neutrophil count decreased Grade 1 to Grade 4 Number Analyzed 61 participants
0
   0.0%
Neutrophil count decreased Grade 2 to Grade 3 Number Analyzed 61 participants
0
   0.0%
Neutrophil count decreased Grade 2 to Grade 4 Number Analyzed 61 participants
0
   0.0%
White blood cell decreased Grade 0 to Grade 3 Number Analyzed 61 participants
1
   1.6%
White blood cell decreased Grade 0 to Grade 4 Number Analyzed 61 participants
0
   0.0%
White blood cell decreased Grade 1 to Grade 3 Number Analyzed 61 participants
0
   0.0%
White blood cell decreased Grade 1 to Grade 4 Number Analyzed 61 participants
0
   0.0%
White blood cell decreased Grade 2 to Grade 3 Number Analyzed 61 participants
0
   0.0%
White blood cell decreased Grade 2 to Grade 4 Number Analyzed 61 participants
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Chemistry Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline
Hide Description Chemistry laboratory parameters included albumin, total protein, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, and lactate dehydrogenase. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 1 (Mild) = asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 (Moderate ) = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.
Time Frame Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received any amount of talazoparib.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
Hyperglycemia Baseline grade not reported to Grade 3
0
   0.0%
Hyperglycemia Baseline grade not reported to Grade 4
0
   0.0%
Hyperglycemia Grade 0 to Grade 3
1
   1.6%
Hyperglycemia Grade 0 to Grade 4
0
   0.0%
Hyperglycemia Grade 1 to Grade 3
0
   0.0%
Hyperglycemia Grade 1 to Grade 4
0
   0.0%
Hyperglycemia Grade 2 to Grade 3
0
   0.0%
Hyperglycemia Grade 2 to Grade 4
0
   0.0%
Hypophosphatemia Baseline grade not reported to Grade 3
0
   0.0%
Hypophosphatemia Baseline grade not reported to Grade 4
0
   0.0%
Hypophosphatemia Grade 0 to Grade 3
1
   1.6%
Hypophosphatemia Grade 0 to Grade 4
0
   0.0%
Hypophosphatemia Grade 1 to Grade 3
0
   0.0%
Hypophosphatemia Grade 1 to Grade 4
0
   0.0%
Hypophosphatemia Grade 2 to Grade 3
0
   0.0%
Hypophosphatemia Grade 2 to Grade 4
0
   0.0%
24.Secondary Outcome
Title Trough Plasma Concentration (Ctrough) of Talazoparib in Cycles 2, 3 and 4 in PK Analysis Set
Hide Description [Not Specified]
Time Frame Pre-dose on Day 1 of Cycles 2, 3, 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit. Number of participants analyzed=number of participants evaluable for this outcome measure. Number analyzed=number of participants evaluable for each time point.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picograms per milliliter (pg/mL)
Cycle 2 Number Analyzed 58 participants
4703
(71.5%)
Cycle 3 Number Analyzed 56 participants
4699
(119.9%)
Cycle 4 Number Analyzed 58 participants
4198
(139.8%)
25.Secondary Outcome
Title Within-Participant Average Ctrough of Talazoparib at Steady State in PK Analysis Set
Hide Description Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
Time Frame Pre-dose on Day 1 of Cycles 2, 3, 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants treated with talazoparib for whom drug plasma concentration results from at least 1 visit were available.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 61
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
4525
(109.5%)
26.Secondary Outcome
Title Ctrough of Talazoparib in Cycles 2, 3 and 4 in Dose-Compliant PK Analysis Set
Hide Description [Not Specified]
Time Frame Pre-dose on Day 1 of Cycles 2, 3, 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit who had received 21 consecutive days of dosing without interruption prior to sample collection. Actual sample collection times were used to determine whether a pre-dose PK sample was dose-compliant. Number of participants analyzed=number of participants evaluable for this outcome measure. Number analyzed=number of participants evaluable for each time point.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
Cycle 2 Number Analyzed 41 participants
5241
(57.9%)
Cycle 3 Number Analyzed 34 participants
5208
(53.8%)
Cycle 4 Number Analyzed 34 participants
4537
(84.6%)
27.Secondary Outcome
Title Within-Participant Average Ctrough of Talazoparib at Steady State in Dose-Compliant PK Analysis Set
Hide Description Within-participant average Ctrough of talazoparib at steady state for each participant was defined as the average (mean) value of the steady state Ctrough values (Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1 trough concentrations) for each individual participant.
Time Frame Pre-dosing on Day 1 of Cycles 2, 3, 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants treated with talazoparib with drug plasma concentration results from at least 1 visit who had received 21 consecutive days of dosing without interruption prior to sample collection. Actual sample collection times were used to determine whether a pre-dose PK sample was dose-compliant.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
5001
(65.2%)
28.Secondary Outcome
Title Number of Participants Who Achieved Definitive Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Per European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-30)
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes (PROs), consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease.

Time Frame Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
19
  37.3%
29.Secondary Outcome
Title Kaplan-Meier Estimate of Time to Definitive Deterioration in GHS/QoL Per EORTC QLQ-30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease.

Time Frame Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(4.6 to NA)
[1]
The median time to definitive deterioration in GHS/QoL and the upper limit of its 95% confidence interval were not estimable as there was insufficient number of participants with definitive deterioration.
30.Secondary Outcome
Title Probability of Not Achieving Definitive Deterioration in GHS/QoL Per EORTC QLQ-C30 at 3 and 6 Months
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much).

For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point decrease from baseline without any subsequent <10 point decrease.

Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using the Kaplan Meier method were reported.

Time Frame 3 months and 6 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of being event-free
3 months
0.696
(0.547 to 0.805)
6 months
0.594
(0.435 to 0.721)
31.Secondary Outcome
Title Number of Participants Who Achieved Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent <10 point increase.

Time Frame Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
9
  17.6%
32.Secondary Outcome
Title Kaplan-Meier Estimate of Time to Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as ≥10 point increase from baseline without any subsequent <10 point increase.

Time Frame Baseline to End of Treatment visit (assessed for maximum of 33 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
[1]
The median time to definitive deterioration in nausea and vomiting symptoms and its 95% confidence interval were not estimable as there was insufficient number of participants with definitive deterioration.
33.Secondary Outcome
Title Probability of Not Achieving Definitive Deterioration in Nausea and Vomiting Symptoms Per EORTC QLQ-C30 at 3 and 6 Months
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, with 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores (1=very poor to 7=excellent); other items have 4 possible scores (1=not at all to 4=very much).

For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A linear transformation was applied to raw scores so that transformed scores lie between 0 to 100, with 0 being the best and 100 being the worst for this symptom scale. A 10 point change from baseline was used to indicate clinically meaningful change. Definitive deterioration was defined as≥10 point increase from baseline without any subsequent <10 point increase. Probability of not achieving definitive deterioration (being event-free) at specified time points (3 and 6 months post-baseline) using Kaplan Meier method were reported.

Time Frame 3 months and 6 months post-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of being event-free
3 months
0.863
(0.734 to 0.932)
6 months
0.818
(0.678 to 0.901)
34.Secondary Outcome
Title Change From Baseline in Global QoL Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the GHS/QoL scale, participants rated their overall health and quality of life within the past week. Negative change from baseline indicates deterioration in GHS/QoL and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-6.0
(-10.43 to -1.59)
Cycle 2 Day 1 Number Analyzed 46 participants
-7.4
(-11.98 to -2.87)
Cycle 2 Day 15 Number Analyzed 44 participants
-5.3
(-9.36 to -1.25)
Cycle 3 Day 1 Number Analyzed 46 participants
-9.1
(-14.70 to -3.42)
Cycle 4 Day 1 Number Analyzed 43 participants
-10.3
(-15.14 to -5.40)
Cycle 5 Day 1 Number Analyzed 39 participants
-13.0
(-19.29 to -6.78)
Cycle 6 Day 1 Number Analyzed 31 participants
-11.3
(-17.17 to -5.41)
End of treatment Number Analyzed 35 participants
-7.9
(-13.00 to -2.71)
Post-surgical follow-up Number Analyzed 30 participants
-13.3
(-19.64 to -7.02)
35.Secondary Outcome
Title Change From Baseline in Physical Functioning Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the physical functioning scale, participants self-rated levels of difficulty in doing strenuous activities, taking a walk, how much they needed to stay in bed or a chair, or needed help with eating, dressing, bathing, using the toilet. Negative change from baseline indicates deterioration in physical functioning and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-3.6
(-5.73 to -1.40)
Cycle 2 Day 1 Number Analyzed 46 participants
-6.1
(-9.12 to -3.05)
Cycle 2 Day 15 Number Analyzed 44 participants
-6.1
(-8.95 to -3.17)
Cycle 3 Day 1 Number Analyzed 46 participants
-8.4
(-12.53 to -4.29)
Cycle 4 Day 1 Number Analyzed 43 participants
-9.3
(-12.66 to -5.95)
Cycle 5 Day 1 Number Analyzed 39 participants
-9.7
(-14.39 to -5.10)
Cycle 6 Day 1 Number Analyzed 31 participants
-9.0
(-13.82 to -4.24)
End of treatment Number Analyzed 35 participants
-5.1
(-8.83 to -1.45)
Post-surgical follow-up Number Analyzed 30 participants
-14.2
(-21.16 to -7.28)
36.Secondary Outcome
Title Change From Baseline in Role Functioning Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the role functioning scale, participants self-rated how much they were limited in doing work or daily activities, or in pursuing hobbies or other leisure time activities during the past week. Negative change from baseline values indicates deterioration in role functioning and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-4.7
(-9.31 to 0.01)
Cycle 2 Day 1 Number Analyzed 46 participants
-9.4
(-14.71 to -4.14)
Cycle 2 Day 15 Number Analyzed 44 participants
-6.4
(-10.97 to -1.91)
Cycle 3 Day 1 Number Analyzed 46 participants
-10.9
(-18.04 to -3.70)
Cycle 4 Day 1 Number Analyzed 43 participants
-8.9
(-13.15 to -4.67)
Cycle 5 Day 1 Number Analyzed 39 participants
-9.4
(-15.94 to -2.87)
Cycle 6 Day 1 Number Analyzed 31 participants
-7.0
(-12.85 to -1.13)
End of treatment Number Analyzed 35 participants
-4.8
(-10.90 to 1.38)
Post-surgical follow-up Number Analyzed 30 participants
-21.7
(-31.49 to -11.84)
37.Secondary Outcome
Title Change From Baseline in Emotional Functioning Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the emotional functioning scale, participants self-rated how much they felt tense, worried, irritable or depressed during the past week. Negative change from baseline values indicates deterioration in emotional functioning and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
2.9
(-2.10 to 7.91)
Cycle 2 Day 1 Number Analyzed 46 participants
0.4
(-4.39 to 5.11)
Cycle 2 Day 15 Number Analyzed 44 participants
1.3
(-3.74 to 6.39)
Cycle 3 Day 1 Number Analyzed 46 participants
-0.9
(-6.05 to 4.24)
Cycle 4 Day 1 Number Analyzed 43 participants
-4.8
(-9.47 to -0.22)
Cycle 5 Day 1 Number Analyzed 39 participants
-3.0
(-8.89 to 2.90)
Cycle 6 Day 1 Number Analyzed 31 participants
-7.8
(-14.54 to -1.06)
End of treatment Number Analyzed 35 participants
-4.0
(-9.87 to 1.78)
Post-surgical follow-up Number Analyzed 30 participants
-3.1
(-10.61 to 4.50)
38.Secondary Outcome
Title Change From Baseline in Cognitive Functioning Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the cognitive functioning scale, participants self-rated the extent of difficulty in concentrating on things or remembering things during the past week. Negative change from baseline values indicates deterioration in cognitive functioning and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-2.3
(-7.02 to 2.37)
Cycle 2 Day 1 Number Analyzed 46 participants
-5.4
(-9.62 to -1.25)
Cycle 2 Day 15 Number Analyzed 44 participants
-5.3
(-9.78 to -0.83)
Cycle 3 Day 1 Number Analyzed 46 participants
-6.9
(-12.93 to -0.84)
Cycle 4 Day 1 Number Analyzed 43 participants
-9.7
(-15.64 to -3.74)
Cycle 5 Day 1 Number Analyzed 39 participants
-7.7
(-13.49 to -1.90)
Cycle 6 Day 1 Number Analyzed 31 participants
-9.7
(-17.69 to -1.66)
End of treatment Number Analyzed 35 participants
-7.1
(-13.84 to -0.44)
Post-surgical follow-up Number Analyzed 30 participants
-7.8
(-16.98 to 1.43)
39.Secondary Outcome
Title Change From Baseline in Social Functioning Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the social functioning scale, participants self-rated how much their physical condition or medical treatment interfered with their family life and social activities during the past week. Negative change from baseline values indicates deterioration in social functioning and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-2.3
(-8.62 to 3.96)
Cycle 2 Day 1 Number Analyzed 46 participants
-4.3
(-9.71 to 1.02)
Cycle 2 Day 15 Number Analyzed 44 participants
-1.9
(-7.16 to 3.37)
Cycle 3 Day 1 Number Analyzed 46 participants
-7.6
(-14.18 to -1.03)
Cycle 4 Day 1 Number Analyzed 43 participants
-5.4
(-10.00 to -0.85)
Cycle 5 Day 1 Number Analyzed 39 participants
-6.0
(-14.25 to 2.28)
Cycle 6 Day 1 Number Analyzed 31 participants
-8.1
(-15.45 to -0.68)
End of treatment Number Analyzed 35 participants
-8.1
(-14.21 to -1.98)
Post-surgical follow-up Number Analyzed 30 participants
-20.6
(-30.59 to -10.52)
40.Secondary Outcome
Title Change From Baseline in Fatigue Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the fatigue symptoms scale, participants self-rated how much they had felt weak, tired or needed to rest during the past week. Negative change from baseline values indicates improvement of fatigue symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
16.3
(9.98 to 22.58)
Cycle 2 Day 1 Number Analyzed 46 participants
18.4
(12.70 to 24.02)
Cycle 2 Day 15 Number Analyzed 44 participants
17.4
(11.58 to 23.27)
Cycle 3 Day 1 Number Analyzed 46 participants
21.0
(13.88 to 28.15)
Cycle 4 Day 1 Number Analyzed 43 participants
22.2
(16.74 to 27.71)
Cycle 5 Day 1 Number Analyzed 39 participants
21.7
(14.45 to 28.85)
Cycle 6 Day 1 Number Analyzed 31 participants
20.4
(12.41 to 28.45)
End of treatment Number Analyzed 35 participants
14.3
(7.32 to 21.25)
Post-surgical follow-up Number Analyzed 30 participants
23.3
(16.33 to 30.34)
41.Secondary Outcome
Title Change From Baseline in Nausea and Vomiting Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. Negative change from baseline values indicates improvement of nausea and vomiting symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
11.2
(6.80 to 15.68)
Cycle 2 Day 1 Number Analyzed 46 participants
8.0
(4.40 to 11.55)
Cycle 2 Day 15 Number Analyzed 44 participants
7.2
(3.67 to 10.72)
Cycle 3 Day 1 Number Analyzed 46 participants
5.4
(1.97 to 8.90)
Cycle 4 Day 1 Number Analyzed 43 participants
3.9
(0.74 to 7.01)
Cycle 5 Day 1 Number Analyzed 39 participants
4.3
(1.06 to 7.49)
Cycle 6 Day 1 Number Analyzed 31 participants
7.5
(2.83 to 12.22)
End of treatment Number Analyzed 35 participants
0.5
(-2.46 to 3.42)
Post-surgical follow-up Number Analyzed 30 participants
1.1
(-2.13 to 4.35)
42.Secondary Outcome
Title Change From Baseline in Pain Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the pain symptoms scale, participants self-rated the extent of pain and how much the pain interfered with daily activities during the past week. Negative change from baseline values indicates improvement of pain symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-1.9
(-6.01 to 2.13)
Cycle 2 Day 1 Number Analyzed 46 participants
-0.0
(-4.78 to 4.78)
Cycle 2 Day 15 Number Analyzed 44 participants
-1.5
(-6.50 to 3.47)
Cycle 3 Day 1 Number Analyzed 46 participants
0.7
(-4.99 to 6.44)
Cycle 4 Day 1 Number Analyzed 43 participants
-2.7
(-7.83 to 2.41)
Cycle 5 Day 1 Number Analyzed 39 participants
1.3
(-6.09 to 8.66)
Cycle 6 Day 1 Number Analyzed 31 participants
-1.1
(-7.76 to 5.61)
End of treatment Number Analyzed 35 participants
1.4
(-4.36 to 7.22)
Post-surgical follow-up Number Analyzed 30 participants
14.4
(6.65 to 22.24)
43.Secondary Outcome
Title Change From Baseline in Dyspnoea Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the dyspnoea symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of dyspnoea symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-0.8
(-2.34 to 0.79)
Cycle 2 Day 1 Number Analyzed 46 participants
5.1
(0.42 to 9.72)
Cycle 2 Day 15 Number Analyzed 44 participants
5.3
(0.44 to 10.16)
Cycle 3 Day 1 Number Analyzed 46 participants
8.0
(2.38 to 13.56)
Cycle 4 Day 1 Number Analyzed 43 participants
16.3
(9.43 to 23.13)
Cycle 5 Day 1 Number Analyzed 39 participants
8.5
(3.16 to 13.93)
Cycle 6 Day 1 Number Analyzed 31 participants
8.6
(2.31 to 14.89)
End of treatment Number Analyzed 35 participants
3.8
(-0.81 to 8.43)
Post-surgical follow-up Number Analyzed 30 participants
4.4
(-2.67 to 11.56)
44.Secondary Outcome
Title Change From Baseline in Insomnia Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the insomnia symptoms scale, participants self-rated the intensity of shortness of breath during the past week. Negative change from baseline values indicates improvement of insomnia symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-4.7
(-12.59 to 3.29)
Cycle 2 Day 1 Number Analyzed 46 participants
-4.3
(-13.10 to 4.41)
Cycle 2 Day 15 Number Analyzed 44 participants
-10.6
(-18.72 to -2.49)
Cycle 3 Day 1 Number Analyzed 46 participants
-6.5
(-14.50 to 1.46)
Cycle 4 Day 1 Number Analyzed 43 participants
-7.0
(-15.52 to 1.56)
Cycle 5 Day 1 Number Analyzed 39 participants
-2.6
(-12.90 to 7.77)
Cycle 6 Day 1 Number Analyzed 31 participants
-6.5
(-18.85 to 5.94)
End of treatment Number Analyzed 35 participants
-4.8
(-16.59 to 7.07)
Post-surgical follow-up Number Analyzed 30 participants
1.1
(-13.68 to 15.90)
45.Secondary Outcome
Title Change From Baseline in Appetite Loss Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the appetite loss symptoms scale, participants self-rated the extent of lack of appetite during the past week. Negative change from baseline values indicates improvement of appetite loss symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
10.1
(2.47 to 17.68)
Cycle 2 Day 1 Number Analyzed 46 participants
3.6
(-3.37 to 10.62)
Cycle 2 Day 15 Number Analyzed 44 participants
0.8
(-6.32 to 7.84)
Cycle 3 Day 1 Number Analyzed 46 participants
5.8
(-2.63 to 14.22)
Cycle 4 Day 1 Number Analyzed 43 participants
3.1
(-3.91 to 10.11)
Cycle 5 Day 1 Number Analyzed 39 participants
4.3
(-3.64 to 12.18)
Cycle 6 Day 1 Number Analyzed 31 participants
4.3
(-4.48 to 13.09)
End of treatment Number Analyzed 35 participants
1.9
(-4.87 to 8.67)
Post-surgical follow-up Number Analyzed 30 participants
2.2
(-5.74 to 10.18)
46.Secondary Outcome
Title Change From Baseline in Constipation Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the constipation symptoms scale, participants self-rated the intensity of constipation during the past week. Negative change from baseline values indicates improvement of constipation symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
12.4
(5.32 to 19.49)
Cycle 2 Day 1 Number Analyzed 46 participants
9.4
(1.71 to 17.13)
Cycle 2 Day 15 Number Analyzed 44 participants
12.1
(4.84 to 19.40)
Cycle 3 Day 1 Number Analyzed 46 participants
8.0
(0.69 to 15.26)
Cycle 4 Day 1 Number Analyzed 43 participants
6.2
(-0.23 to 12.63)
Cycle 5 Day 1 Number Analyzed 39 participants
7.7
(0.48 to 14.90)
Cycle 6 Day 1 Number Analyzed 31 participants
5.4
(-4.65 to 15.41)
End of treatment Number Analyzed 35 participants
3.8
(-1.58 to 9.20)
Post-surgical follow-up Number Analyzed 30 participants
3.3
(-4.90 to 11.57)
47.Secondary Outcome
Title Change From Baseline in Diarrhea Symptoms Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the diarrhea symptoms scale, participants self-rated the intensity of diarrhea during the past week. Negative change from baseline values indicates improvement of diarrhea symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
1.6
(-2.30 to 5.40)
Cycle 2 Day 1 Number Analyzed 46 participants
2.2
(-1.68 to 6.02)
Cycle 2 Day 15 Number Analyzed 44 participants
1.5
(-2.24 to 5.27)
Cycle 3 Day 1 Number Analyzed 46 participants
0.0
(-2.09 to 2.09)
Cycle 4 Day 1 Number Analyzed 43 participants
2.3
(-1.14 to 5.79)
Cycle 5 Day 1 Number Analyzed 39 participants
3.4
(-1.41 to 8.25)
Cycle 6 Day 1 Number Analyzed 31 participants
0.0
(-4.46 to 4.46)
End of treatment Number Analyzed 35 participants
1.9
(-0.79 to 4.60)
Post--surgical follow-up Number Analyzed 30 participants
1.1
(-2.87 to 5.09)
48.Secondary Outcome
Title Change From Baseline in Financial Difficulties Per EORTC QLQ-C30
Hide Description

EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the symptom scale of financial difficulties, participants self-rated how much their physical condition or medical treatment caused financial difficulties. Negative change from baseline values indicates improvement of financial difficulties and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-3.9
(-8.47 to 0.72)
Cycle 2 Day 1 Number Analyzed 46 participants
-1.4
(-9.52 to 6.62)
Cycle 2 Day 15 Number Analyzed 44 participants
-3.0
(-11.15 to 5.09)
Cycle 3 Day 1 Number Analyzed 46 participants
-0.7
(-8.39 to 6.94)
Cycle 4 Day 1 Number Analyzed 43 participants
1.6
(-6.81 to 9.91)
Cycle 5 Day 1 Number Analyzed 39 participants
5.1
(-5.25 to 15.51)
Cycle 6 Day 1 Number Analyzed 31 participants
3.2
(-8.31 to 14.76)
End of treatment Number Analyzed 35 participants
10.5
(-0.20 to 21.15)
Post-surgical follow-up Number Analyzed 30 participants
16.7
(4.55 to 28.79)
49.Secondary Outcome
Title Change From Baseline in Body Image Per EORTC QLQ Breast Cancer Quality of Life Questionnaire (EORTC QLQ-BR23)
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the functional scale of body image, participants self-rated how much they felt physically less attractive or less feminine, difficult to look at themselves naked, or dissatisfied with their body during the past week. Negative change from baseline indicates worsening of self-rated body image and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 49
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
0.2
(-2.79 to 3.18)
Cycle 2 Day 1 Number Analyzed 44 participants
1.7
(-1.37 to 4.78)
Cycle 2 Day 15 Number Analyzed 43 participants
-0.2
(-3.84 to 3.45)
Cycle 3 Day 1 Number Analyzed 45 participants
-0.4
(-3.53 to 2.79)
Cycle 4 Day 1 Number Analyzed 42 participants
-6.3
(-11.11 to -1.59)
Cycle 5 Day 1 Number Analyzed 38 participants
-9.4
(-15.17 to -3.69)
Cycle 6 Day 1 Number Analyzed 30 participants
-6.1
(-11.08 to -1.14)
End of treatment Number Analyzed 34 participants
-6.9
(-12.10 to -1.63)
Post-surgical follow-up Number Analyzed 29 participants
-13.8
(-20.64 to -6.95)
50.Secondary Outcome
Title Change From Baseline in Sexual Functioning Per EORTC QLQ-BR23
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the sexual functioning scale, participants self-rated to what extent they were interested in sex and were sexually active (with or without intercourse) during the past 4 weeks. Negative change from baseline values indicates worsening of sexual functioning and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 49
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-1.6
(-7.45 to 4.35)
Cycle 2 Day 1 Number Analyzed 44 participants
-3.0
(-9.33 to 3.27)
Cycle 2 Day 15 Number Analyzed 43 participants
-2.7
(-8.73 to 3.31)
Cycle 3 Day 1 Number Analyzed 45 participants
-0.4
(-7.33 to 6.59)
Cycle 4 Day 1 Number Analyzed 42 participants
-1.2
(-8.39 to 6.01)
Cycle 5 Day 1 Number Analyzed 38 participants
-3.5
(-11.17 to 4.15)
Cycle 6 Day 1 Number Analyzed 30 participants
-2.8
(-11.59 to 6.04)
End of treatment Number Analyzed 34 participants
-3.4
(-11.11 to 4.25)
Post-surgical follow-up Number Analyzed 29 participants
-10.9
(-20.55 to -1.29)
51.Secondary Outcome
Title Change From Baseline in Sexual Enjoyment Per EORTC QLQ-BR23
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the functional scale of sexual enjoyment, participants self-rated to what extent sex was enjoyable for them during the past 4 weeks. Negative change from baseline values indicates worsening of sexual enjoyment and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 26
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 20 participants
-3.3
(-11.95 to 5.29)
Cycle 2 Day 1 Number Analyzed 21 participants
0.0
(-11.75 to 11.75)
Cycle 2 Day 15 Number Analyzed 18 participants
-3.7
(-16.28 to 8.87)
Cycle 3 Day 1 Number Analyzed 19 participants
-10.5
(-21.31 to 0.25)
Cycle 4 Day 1 Number Analyzed 19 participants
-12.3
(-23.27 to -1.29)
Cycle 5 Day 1 Number Analyzed 17 participants
-5.9
(-18.35 to 6.59)
Cycle 6 Day 1 Number Analyzed 13 participants
-12.8
(-28.29 to 2.65)
End of treatment Number Analyzed 15 participants
-13.3
(-30.14 to 3.47)
Post-surgical follow-up Number Analyzed 9 participants
-18.5
(-37.13 to 0.10)
52.Secondary Outcome
Title Change From Baseline in Future Perspective Per EORTC QLQ-BR23
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the functional scale of future perspective, participants self-rated how much they were worried about their health in the future. Negative change from baseline values indicates worsening of future perspective and positive change indicates improvement.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 49
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
3.1
(-3.91 to 10.11)
Cycle 2 Day 1 Number Analyzed 44 participants
11.4
(3.50 to 19.23)
Cycle 2 Day 15 Number Analyzed 43 participants
11.6
(3.91 to 19.34)
Cycle 3 Day 1 Number Analyzed 45 participants
5.9
(-2.42 to 14.27)
Cycle 4 Day 1 Number Analyzed 42 participants
5.6
(-2.36 to 13.48)
Cycle 5 Day 1 Number Analyzed 38 participants
6.1
(-1.86 to 14.14)
Cycle 6 Day 1 Number Analyzed 30 participants
6.7
(-3.87 to 17.21)
End of treatment Number Analyzed 34 participants
-2.0
(-12.26 to 8.34)
Post-surgical follow-up Number Analyzed 29 participants
10.3
(-0.95 to 21.64)
53.Secondary Outcome
Title Change From Baseline in Systemic Therapy Side Effects Per EORTC QLQ-BR23
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the systemic therapy side effects scale, participants self-rated the intensity of symptoms of dry mouth, unusual taste, pain and irritation of eyes, hair loss, feeling ill or unwell, hot flushes and headaches during the past week. Negative change from baseline= improvement of these side effects, positive change = deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 49
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
7.1
(3.74 to 10.43)
Cycle 2 Day 1 Number Analyzed 44 participants
6.6
(3.70 to 9.50)
Cycle 2 Day 15 Number Analyzed 43 participants
9.1
(5.90 to 12.26)
Cycle 3 Day 1 Number Analyzed 45 participants
11.2
(7.57 to 14.87)
Cycle 4 Day 1 Number Analyzed 42 participants
15.0
(10.93 to 19.00)
Cycle 5 Day 1 Number Analyzed 38 participants
13.5
(9.10 to 17.97)
Cycle 6 Day 1 Number Analyzed 30 participants
16.5
(11.57 to 21.44)
End of treatment Number Analyzed 34 participants
6.9
(3.22 to 10.50)
Post-surgical follow-up Number Analyzed 29 participants
3.3
(-0.28 to 6.84)
54.Secondary Outcome
Title Change From Baseline in Breast Symptoms Per EORTC QLQ-BR23
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the breast symptoms scale, participants self-rated how much they had pain or skin problems (e.g. itchy, dry, flaky) on or in the area of affected breast, and how much this area was swollen or oversensitive during the past week. Negative change from baseline indicates improvement of breast symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 49
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-2.1
(-5.97 to 1.71)
Cycle 2 Day 1 Number Analyzed 44 participants
-4.9
(-9.02 to -0.82)
Cycle 2 Day 15 Number Analyzed 43 participants
-9.1
(-13.61 to -4.60)
Cycle 3 Day 1 Number Analyzed 45 participants
-8.0
(-12.20 to -3.73)
Cycle 4 Day 1 Number Analyzed 42 participants
-5.6
(-9.72 to -1.39)
Cycle 5 Day 1 Number Analyzed 38 participants
-7.7
(-12.75 to -2.61)
Cycle 6 Day 1 Number Analyzed 30 participants
-6.4
(-11.85 to -0.93)
End of treatment Number Analyzed 34 participants
0.2
(-5.55 to 6.04)
Post-surgical follow-up Number Analyzed 29 participants
8.6
(-0.16 to 17.40)
55.Secondary Outcome
Title Change From Baseline in Arm Symptoms Per EORTC QLQ-BR23
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the arm symptoms scale, participants self-rated how much they had pain in the arm or shoulder, how much the arm or hand was swollen, and difficulty in raising the arm or moving it sideways. Negative change from baseline indicates improvement of arm symptoms and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 49
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 43 participants
-1.6
(-4.59 to 1.49)
Cycle 2 Day 1 Number Analyzed 44 participants
-0.8
(-4.05 to 2.53)
Cycle 2 Day 15 Number Analyzed 43 participants
-1.6
(-5.25 to 2.15)
Cycle 3 Day 1 Number Analyzed 45 participants
-0.7
(-4.40 to 2.92)
Cycle 4 Day 1 Number Analyzed 42 participants
-1.3
(-4.40 to 1.76)
Cycle 5 Day 1 Number Analyzed 38 participants
0.3
(-3.73 to 4.32)
Cycle 6 Day 1 Number Analyzed 30 participants
-1.5
(-6.20 to 3.23)
End of treatment Number Analyzed 34 participants
-1.0
(-5.18 to 3.22)
Post-surgical follow-up Number Analyzed 29 participants
13.0
(5.70 to 20.35)
56.Secondary Outcome
Title Change From Baseline in Upset by Hair Loss Per EORTC QLQ-BR23
Hide Description

EORTC-QLQ-BR23 is a 23-item breast cancer module developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer, consisting of 2 functional scales, 3 symptoms scales, and 3 single-item scales. Each scale has 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for functional scales, and 0 being the best and 100 being the worst for symptoms scales.

For the upset by hair loss scale, participants self-rated how upset they were due to loss of hair during the past week. Negative change from baseline values indicates improvement of upset by hair loss and positive change indicates deterioration.

Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed refers to participants who completed the PRO assessment of this outcome measure at baseline and had at least 1 post-baseline assessment of this outcome measure prior to end of study treatment. Number Analyzed refers to those who completed the PRO assessment of this outcome measure at both baseline and each specific visit. "Number Analyzed" may or may not be smaller than "Number of participants analyzed" due to individual missing values.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 3
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Cycle 1 Day 15 Number Analyzed 1 participants
0.0 [1] 
(NA to NA)
Cycle 2 Day 1 Number Analyzed 2 participants
-33.3
(-456.87 to 390.21)
Cycle 2 Day 15 Number Analyzed 3 participants
-11.1
(-137.60 to 115.37)
Cycle 3 Day 1 Number Analyzed 2 participants
33.33
(33.33 to 33.33)
Cycle 4 Day 1 Number Analyzed 3 participants
11.1
(-161.26 to 183.48)
Cycle 5 Day 1 Number Analyzed 0 participants
Cycle 6 Day 1 Number Analyzed 0 participants
End of treatment Number Analyzed 1 participants
33.33 [1] 
(NA to NA)
Post-surgical follow-up Number Analyzed 1 participants
33.3 [1] 
(NA to NA)
[1]
95% CI was not reported for n=1
57.Secondary Outcome
Title Number of Participants With Deterioration in Nausea/Vomiting Symptoms
Hide Description EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Deterioration in nausea and vomiting symptoms was defined as a 10 point or more increase from baseline for that specific time point.
Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 1 Day 15 Number Analyzed 43 participants
21
  48.8%
Cycle 2 Day 1 Number Analyzed 46 participants
20
  43.5%
Cycle 2 Day 15 Number Analyzed 44 participants
18
  40.9%
Cycle 3 Day 1 Number Analyzed 46 participants
14
  30.4%
Cycle 4 Day 1 Number Analyzed 43 participants
10
  23.3%
Cycle 5 Day 1 Number Analyzed 39 participants
11
  28.2%
Cycle 6 Day 1 Number Analyzed 31 participants
10
  32.3%
End of treatment Number Analyzed 35 participants
3
   8.6%
Post-surgical follow-up Number Analyzed 30 participants
5
  16.7%
58.Secondary Outcome
Title Number of Participants With Improvement in Nausea/Vomiting Symptoms
Hide Description EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. Improvement in nausea and vomiting symptoms was defined as a 10 point or more decrease from baseline for that specific time point.
Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 1 Day 15 Number Analyzed 43 participants
1
   2.3%
Cycle 2 Day 1 Number Analyzed 46 participants
2
   4.3%
Cycle 2 Day 15 Number Analyzed 44 participants
2
   4.5%
Cycle 3 Day 1 Number Analyzed 46 participants
2
   4.3%
Cycle 4 Day 1 Number Analyzed 43 participants
2
   4.7%
Cycle 5 Day 1 Number Analyzed 39 participants
2
   5.1%
Cycle 6 Day 1 Number Analyzed 31 participants
0
   0.0%
End of treatment Number Analyzed 35 participants
3
   8.6%
Post-surgical follow-up Number Analyzed 30 participants
3
  10.0%
59.Secondary Outcome
Title Number of Participants With No Change in Nausea/Vomiting Symptoms
Hide Description EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a GHS/QoL scale, and 6 single-item scales. The GHS/QoL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all to 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS/QoL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. For the nausea and vomiting symptoms scale, participants self-rated how much they had felt nauseated and/or vomited during the past week. A 10 point change from baseline was used to indicate clinically meaningful change. No change in nausea/vomiting symptoms=having neither deterioration (≥10 point increase from baseline) nor improvement (≥10 point decrease from baseline) for the time point.
Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least one post-baseline QoL assessment prior to end of study treatment. Number of Participants Analyzed refers to participants who were evaluable for this outcome measure. Number analyzed refers to participants who were evaluable for this outcome measure at the specific visit.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
Cycle 1 Day 15 Number Analyzed 43 participants
21
  48.8%
Cycle 2 Day 1 Number Analyzed 46 participants
24
  52.2%
Cycle 2 Day 15 Number Analyzed 44 participants
24
  54.5%
Cycle 3 Day 1 Number Analyzed 46 participants
30
  65.2%
Cycle 4 Day 1 Number Analyzed 43 participants
31
  72.1%
Cycle 5 Day 1 Number Analyzed 39 participants
26
  66.7%
Cycle 6 Day 1 Number Analyzed 31 participants
21
  67.7%
End of treatment Number Analyzed 35 participants
29
  82.9%
Post-surgical follow-up Number Analyzed 30 participants
22
  73.3%
60.Secondary Outcome
Title Number of Participants With Missed Expected Menstrual Periods Per Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Hide Description Missed expected menstrual period was assessed electronically using the PRO CTCAE questionnaire, a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This objective captures the concept of fertility preservation through PRO, since there is a possible fertility sparing effect of talazoparib versus chemotherapy.
Time Frame Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Day 1 of Cycles 3-6, End of Treatment visit (maximum of 33 weeks) and Post-surgical follow-up visit (maximum of 41 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who completed a baseline and at least 1 post-baseline QoL assessment prior to the end of the study treatment. Post-menopausal participants were excluded from this evaluation. Number of participants analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description:

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 30 participants
0
   0.0%
Cycle 1 Day 15 Number Analyzed 24 participants
1
   4.2%
Cycle 2 Day 1 Number Analyzed 27 participants
0
   0.0%
Cycle 2 Day 15 Number Analyzed 27 participants
2
   7.4%
Cycle 3 Day 1 Number Analyzed 30 participants
0
   0.0%
Cycle 4 Day 1 Number Analyzed 26 participants
3
  11.5%
Cycle 5 Day 1 Number Analyzed 23 participants
1
   4.3%
Cycle 6 Day 1 Number Analyzed 18 participants
1
   5.6%
End of treatment Number Analyzed 19 participants
0
   0.0%
Post-surgical follow-up Number Analyzed 15 participants
1
   6.7%
Time Frame Adverse events were assessed from Baseline to 28 days after the last dose of talazoparib (maximum of approximately 8 months). All-cause mortality was assessed from Baseline until participant died or withdrew consent for follow-up, or study termination (maximum of approximately 16 months).
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
 
Arm/Group Title Talazoparib 1 mg QD
Hide Arm/Group Description

During talazoparib treatment period, participants received oral administration of talazoparib 1 mg once daily (QD) for 24 weeks (6 cycles, 4 weeks per cycle), or 0.75 mg QD in case of moderate renal impairment at baseline, followed by definitive breast surgery within a maximum of 6 weeks of last dose.

Safety follow-up (end of treatment visit) occurred approximately 28 calendar days after the last dose of talazoparib or after permanent treatment discontinuation or before initiation of a new antineoplastic therapy (whichever occurred first).

Long-term follow-up was planned to be at least 3 years, which started from the date of surgery for event-free survival (EFS) and after first dose of talazoparib for overall survival (OS).

All-Cause Mortality
Talazoparib 1 mg QD
Affected / at Risk (%)
Total   2/61 (3.28%) 
Hide Serious Adverse Events
Talazoparib 1 mg QD
Affected / at Risk (%)
Total   11/61 (18.03%) 
Blood and lymphatic system disorders   
Anaemia * 1  9/61 (14.75%) 
Neutropenia * 1  1/61 (1.64%) 
Gastrointestinal disorders   
Intestinal obstruction * 1  1/61 (1.64%) 
General disorders   
Influenza like illness * 1  1/61 (1.64%) 
1
Term from vocabulary, MedDRA v23.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Talazoparib 1 mg QD
Affected / at Risk (%)
Total   60/61 (98.36%) 
Blood and lymphatic system disorders   
Anaemia * 1  30/61 (49.18%) 
Gastrointestinal disorders   
Abdominal pain * 1  4/61 (6.56%) 
Constipation * 1  19/61 (31.15%) 
Diarrhoea * 1  13/61 (21.31%) 
Dry mouth * 1  4/61 (6.56%) 
Gastrooesophageal reflux disease * 1  4/61 (6.56%) 
Nausea * 1  42/61 (68.85%) 
Stomatitis * 1  6/61 (9.84%) 
Vomiting * 1  7/61 (11.48%) 
General disorders   
Fatigue * 1  48/61 (78.69%) 
Infections and infestations   
Upper respiratory tract infection * 1  12/61 (19.67%) 
Urinary tract infection * 1  4/61 (6.56%) 
Investigations   
Alanine aminotransferase increased * 1  7/61 (11.48%) 
Neutrophil count decreased * 1  9/61 (14.75%) 
White blood cell count decreased * 1  9/61 (14.75%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  8/61 (13.11%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  11/61 (18.03%) 
Back pain * 1  5/61 (8.20%) 
Myalgia * 1  9/61 (14.75%) 
Pain in extremity * 1  6/61 (9.84%) 
Nervous system disorders   
Dizziness * 1  20/61 (32.79%) 
Dysgeusia * 1  5/61 (8.20%) 
Headache * 1  26/61 (42.62%) 
Psychiatric disorders   
Anxiety * 1  11/61 (18.03%) 
Insomnia * 1  11/61 (18.03%) 
Reproductive system and breast disorders   
Breast pain * 1  7/61 (11.48%) 
Menstruation irregular * 1  4/61 (6.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  9/61 (14.75%) 
Dyspnoea * 1  10/61 (16.39%) 
Nasal congestion * 1  6/61 (9.84%) 
Oropharyngeal pain * 1  7/61 (11.48%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  35/61 (57.38%) 
Pruritus * 1  5/61 (8.20%) 
Rash * 1  7/61 (11.48%) 
Vascular disorders   
Hot flush * 1  7/61 (11.48%) 
Hypertension * 1  6/61 (9.84%) 
1
Term from vocabulary, MedDRA v23.1
*
Indicates events were collected by non-systematic assessment
The study was prematurely terminated by the sponsor due to a change in clinical development strategy not related to safety or efficacy after all participants completed safety follow-up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03499353    
Other Study ID Numbers: C3441020
TALAZOPARIB NEOADJ BC ( Other Identifier: Alias Study Number )
First Submitted: April 9, 2018
First Posted: April 17, 2018
Results First Submitted: August 20, 2021
Results First Posted: November 9, 2021
Last Update Posted: November 9, 2021