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A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) (ABRAZO)

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ClinicalTrials.gov Identifier: NCT02034916
Recruitment Status : Terminated (Primary Analysis and study completed. Not stopped due to safety concerns.)
First Posted : January 14, 2014
Results First Posted : November 6, 2017
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
Myriad Genetic Laboratories, Inc.
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Intervention Drug: talazoparib
Enrollment 84
Recruitment Details  
Pre-assignment Details In this study, enrollment of participants was to be done in 2 stages for each of the two cohorts. Sufficient responses in each cohort were observed such that enrollment could proceed to Stage 2 for both cohorts. However, due to Sponsor decision, enrollment in the overall trial was terminated early.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 milligram (mg) orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter. Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Period Title: Overall Study
Started 49 35
Treated 48 35
Completed 0 0
Not Completed 49 35
Reason Not Completed
Death             32             13
Withdrawal by Subject             1             1
Lost to Follow-up             1             1
Ongoing as of data cutoff (01 Sep 2016)             15             20
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg Total
Hide Arm/Group Description Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter. Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter. Total of all reporting groups
Overall Number of Baseline Participants 49 35 84
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population involved all enrolled participants including participants who were not treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 35 participants 84 participants
50.1  (11.48) 53.4  (11.05) 51.5  (11.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 35 participants 84 participants
Female
48
  98.0%
34
  97.1%
82
  97.6%
Male
1
   2.0%
1
   2.9%
2
   2.4%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR: Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1). CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to less than (<) 10 millimeter (mm) in short axis. PR: Greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions, compared to the sum at baseline. Response evaluation was done by an independent radiology facility (IRF).
Time Frame From randomization until data cutoff date (01 Sep 2016)
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor-evaluable population (TEP) included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan plus (+) 1 week window.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 48 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.8
(10.47 to 34.99)
37.1
(21.47 to 55.08)
2.Secondary Outcome
Title Clinical Benefit Rate-24 (CBR-24)
Hide Description CBR24: Percentage of participants with a best response of CR, PR or stable disease (SD) sustained for at least 24 weeks, as assessed by IRF using RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. SD: Neither PR nor progression of disease (PD) criteria met. SD follow PR only when sum increases by less than 20% from the nadir, but previously seen 30% decrease from baseline no longer hold. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions.
Time Frame From randomization until data cutoff date (01 Sep 2016)
Hide Outcome Measure Data
Hide Analysis Population Description
TEP included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan + 1 week window.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 48 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.1
(15.28 to 41.85)
45.7
(28.83 to 63.35)
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR: Time from first documentation of CR or PR, to PD by IRF assessment using RECIST 1.1, or to death due to any cause, whichever occurred first. CR: Disappearance of all non-nodal target and non-target lesions, with target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PD or death at the analysis date were censored at last tumor assessment date prior to on or before initiation of a new anticancer therapy or before the data cutoff date.
Time Frame From first documentation of CR or PR until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
TEP included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan + 1 week window. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 10 13
Median (95% Confidence Interval)
Unit of Measure: months
5.8 [1] 
(2.8 to NA)
3.8
(2.8 to 10.1)
[1]
Upper limit of 95% confidence interval was not reached due to insufficient number of events at the time of data cutoff (01 Sep 2016).
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time in months from the first dose of study drug to the first documentation of PD by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PFS event at the analysis were censored at last tumor assessment date prior to data cutoff or date of new anticancer treatment initiation, whichever occurred first.
Time Frame From first dose of study drug until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population involved all enrolled participants including participants who were not treated.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 49 35
Median (95% Confidence Interval)
Unit of Measure: months
4.0
(2.8 to 5.4)
5.6
(5.5 to 7.8)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from first dose of study drug to death due to any cause. For participants without a death date at the time of data cutoff or permanently lost to follow-up, OS was right-censored at the date the participant was last known to be alive on or before the data cutoff date.
Time Frame From first dose of study drug until death due to any cause (up to the data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population involved all enrolled participants including participants who were not treated.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 49 35
Median (95% Confidence Interval)
Unit of Measure: months
11.8
(8.8 to 15.0)
16.5 [1] 
(10.1 to NA)
[1]
Upper limit of 95% confidence interval was not reached due to insufficient number of events at the time of data cutoff (01 Sep 2016).
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria . A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.
Time Frame Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 48 35
Measure Type: Number
Unit of Measure: participants
AEs 47 34
SAEs 16 7
7.Secondary Outcome
Title Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A treatment-related SAE was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria.
Time Frame Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of talazoparib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 47 34
Measure Type: Number
Unit of Measure: participants
AEs 46 33
SAEs 7 3
8.Secondary Outcome
Title Number of Participants With Outcome in Response to Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: ‘Is the AE leading to study discontinuation or death?’ as ‘yes’.
Time Frame Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of talazoparib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 47 34
Measure Type: Number
Unit of Measure: participants
AEs leading to study drug discontinuation 4 1
AEs leading to death 4 0
9.Secondary Outcome
Title Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameters
Hide Description Laboratory tests included hematology (hemoglobin [low], leucocytes [low], lymphocytes [low], neutrophils [low], platelets [low]) and serum chemistry (alanine aminotransferase [high], albumin [low], alkaline phosphatase [high], aspartate aminotransferase [high], bilirubin [high], calcium [low], glucose [high], magnesium [low], phosphate [low], potassium [high], potassium [low], sodium [high], sodium [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for hematology and chemistry laboratory parameters is reported in this outcome measure.
Time Frame Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 48 35
Measure Type: Number
Unit of Measure: participants
Hemoglobin (low) 19 16
Leukocytes (low) 16 15
Lymphocytes (low) 14 4
Neutrophils (low) 20 17
Platelets (low) 21 10
Alanine aminotransferase (high) 3 2
Albumin (low) 3 0
Alkaline phosphatase (high) 1 1
Aspartate aminotransferase (high) 2 1
Bilirubin (high) 2 0
Calcium (low) 4 1
Glucose (high) 1 1
Magnesium (low) 1 0
Phosphate (low) 6 2
Potassium (high) 1 0
Potassium (low) 2 0
Sodium (high) 1 0
Sodium (low) 0 1
10.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description Criteria for clinically significant vital sign changes: 1) Blood pressure: systolic blood pressure (SBP): >=30 millimeters of mercury (mmHg) increase from baseline, diastolic blood pressure (DBP): >=20 mmHg decrease from baseline; 2) Heart rate (HR): absolute HR > 120 beats per minute (bpm) and >30 bpm increase from baseline, absolute HR <50 bpm and >20 bpm decrease from baseline; 3) Weight: >10% decrease from baseline. Number of participants with any clinically significant change in abnormalities for blood pressure, heart rate and weight are reported in this outcome measure.
Time Frame Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 48 35
Measure Type: Number
Unit of Measure: participants
Blood pressure (SBP or DBP) 20 18
HR 2 0
Weight 4 1
11.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Physical Findings
Hide Description Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator’s decision.
Time Frame Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population involved all enrolled participants including participants who were not treated.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 49 35
Measure Type: Number
Unit of Measure: participants
0 0
12.Secondary Outcome
Title Number of Participants With Atleast 1 Concomitant Medication
Hide Description Number of participants taking any non-study medications, therapies, including herbal supplements during the treatment-emergent period for the management of an adverse event or for the treatment of any other disease.
Time Frame From first dose of study drug up to 30 days after the last dose or before initiation of a new anticancer treatment, whichever occurred first (up to the data cutoff date [01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 48 35
Measure Type: Number
Unit of Measure: participants
48 34
13.Secondary Outcome
Title Trough Concentration Versus Time Summary of Talazoparib
Hide Description Concentrations below the limit of quantitation values less than or equal to (<=) 25 picogram per milliliter (pg/mL) were set as zero. Pharmacokinetic (PK) analysis was not done separately for each reporting arm and cohorts were combined for PK analysis.
Time Frame Predose on Day 1 of Cycle 1, 2, 3 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received at least 1 dose of talazoparib and had evaluable PK assessments.
Arm/Group Title Cohort 1 + Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants, who either responded to a prior platinum-containing treatment for metastatic breast cancer or had more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. For the participants with non-platinum chemotherapy, prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 83
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 1 of Cycle 1 Number Analyzed 82 participants
10.3  (93.3)
Day 1 of Cycle 2 Number Analyzed 70 participants
4220  (2510)
Day 1 of Cycle 3 Number Analyzed 68 participants
3990  (2840)
Day 1 of Cycle 4 Number Analyzed 60 participants
3090  (2170)
14.Other Pre-specified Outcome
Title Time to Deterioration in Global Health Status/Quality of Life (QOL) and Functional Status as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Hide Description Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the functional status score and global health status/QOL score based on the EORTC-QLQ-C30, whichever occurred first. EORTC-QLQ-C30 questionnaire is a standardized instrument developed to assess the quality of life of people with cancer. EORTC-QLQ-C30 functional subscale includes 5 items: physical, role, emotional, cognitive, and social functioning. All of the single items of functional status subscale measures and global health status/QOL subscale range from 0 to 100, where higher scores represent a better level of functioning/quality of life.
Time Frame Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])
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Hide Analysis Population Description
ITT population involved all enrolled participants including participants who were not treated.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 49 35
Median (95% Confidence Interval)
Unit of Measure: months
Global Health Status/QOL
2.8
(2.1 to 3.0)
5.5
(4.2 to 5.7)
Physical Functioning
3.1
(2.1 to 4.6)
5.6
(5.3 to 7.7)
Role Functioning
2.1
(1.4 to 2.8)
4.2
(2.1 to 5.5)
Emotional Functioning
2.7
(2.0 to 2.8)
5.5
(4.3 to 5.6)
Cognitive Functioning
2.7
(1.6 to 3.2)
4.2
(2.8 to 5.5)
Social Functioning
2.2
(1.4 to 2.9)
5.3
(4.1 to 5.6)
15.Other Pre-specified Outcome
Title Time to Deterioration in Disease Specific Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)
Hide Description Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the symptom score based on the EORTC-QLQ-BR23, whichever occurred first. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much) within each scale.
Time Frame Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population involved all enrolled participants including participants who were not treated.
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description:
Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
Overall Number of Participants Analyzed 49 35
Median (95% Confidence Interval)
Unit of Measure: months
Systemic Therapy Side Effects
2.8
(2.3 to 4.0)
5.5
(4.1 to 5.6)
Breast Symptoms
3.1
(2.5 to 4.6)
5.6
(5.3 to 7.7)
Arm Symptoms
2.6
(2.0 to 3.7)
4.2
(2.8 to 5.5)
Upset by Hair Loss
4.0
(2.7 to 5.4)
5.6
(5.3 to 7.7)
Time Frame Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])
Adverse Event Reporting Description Same event may appear as both an AE and a SAE. However, what is presented are distinct events. 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. AEs and SAEs were collected for safety population.
 
Arm/Group Title Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Hide Arm/Group Description Participants who responded to a prior platinum-containing treatment for metastatic breast cancer, with disease progression of at least 8 weeks following the last dose of platinum, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter. Participants with more than 2 prior non-platinum chemotherapy treatment for metastatic breast cancer, received talazoparib 1.0 mg orally, once daily for 21 days in repeated 21-day cycles until disease progression, occurrence of unacceptable toxicity or permanent treatment discontinuation. Prior adjuvant or neo-adjuvant therapy with a platinum was allowed if first disease recurrence was for more than 6 months since last dose of adjuvant/neo-adjuvant platinum treatment. Participants were followed-up for survival and new anticancer treatment at every 60 days after the last dose of study drug for the first year, every 90 days thereafter.
All-Cause Mortality
Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   16/48 (33.33%)   7/35 (20.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  5/48 (10.42%)  0/35 (0.00%) 
Thrombocytopenia * 1  2/48 (4.17%)  1/35 (2.86%) 
Anaemia of malignant disease * 1  1/48 (2.08%)  0/35 (0.00%) 
Gastrointestinal disorders     
Oesophagitis * 1  1/48 (2.08%)  0/35 (0.00%) 
Infections and infestations     
Bronchopneumonia * 1  1/48 (2.08%)  0/35 (0.00%) 
Neutropenic sepsis * 1  0/48 (0.00%)  1/35 (2.86%) 
Pneumonia * 1  1/48 (2.08%)  0/35 (0.00%) 
Injury, poisoning and procedural complications     
Transfusion reaction * 1  1/48 (2.08%)  0/35 (0.00%) 
Investigations     
Platelet count decreased * 1  1/48 (2.08%)  1/35 (2.86%) 
Metabolism and nutrition disorders     
Hypokalaemia * 1  1/48 (2.08%)  0/35 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/48 (2.08%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm progression * 1  3/48 (6.25%)  0/35 (0.00%) 
Breast cancer metastatic * 1  2/48 (4.17%)  0/35 (0.00%) 
Silicon granuloma * 1  1/48 (2.08%)  0/35 (0.00%) 
Nervous system disorders     
Central nervous system lesion * 1  1/48 (2.08%)  0/35 (0.00%) 
Presyncope * 1  1/48 (2.08%)  0/35 (0.00%) 
Syncope * 1  1/48 (2.08%)  0/35 (0.00%) 
Psychiatric disorders     
Anxiety * 1  1/48 (2.08%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  3/48 (6.25%)  2/35 (5.71%) 
Dyspnoea * 1  2/48 (4.17%)  2/35 (5.71%) 
Atelectasis * 1  1/48 (2.08%)  0/35 (0.00%) 
Pulmonary embolism * 1  1/48 (2.08%)  0/35 (0.00%) 
Surgical and medical procedures     
Lipoinjection * 1  1/48 (2.08%)  0/35 (0.00%) 
Salpingo-oophorectomy * 1 [1]  1/47 (2.13%)  0/34 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
[1]
Gender specific event.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Talazoparib 1 mg Cohort 2: Talazoparib 1 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   47/48 (97.92%)   34/35 (97.14%) 
Blood and lymphatic system disorders     
Anaemia * 1  23/48 (47.92%)  19/35 (54.29%) 
Leukopenia * 1  7/48 (14.58%)  6/35 (17.14%) 
Lymphopenia * 1  2/48 (4.17%)  4/35 (11.43%) 
Neutropenia * 1  10/48 (20.83%)  12/35 (34.29%) 
Thrombocytopenia * 1  18/48 (37.50%)  9/35 (25.71%) 
Cardiac disorders     
Tachycardia * 1  2/48 (4.17%)  2/35 (5.71%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/48 (2.08%)  2/35 (5.71%) 
Abdominal distension * 1  1/48 (2.08%)  3/35 (8.57%) 
Abdominal pain * 1  7/48 (14.58%)  7/35 (20.00%) 
Abdominal pain upper * 1  2/48 (4.17%)  6/35 (17.14%) 
Constipation * 1  9/48 (18.75%)  6/35 (17.14%) 
Diarrhoea * 1  17/48 (35.42%)  10/35 (28.57%) 
Dry mouth * 1  0/48 (0.00%)  2/35 (5.71%) 
Dyspepsia * 1  5/48 (10.42%)  3/35 (8.57%) 
Nausea * 1  20/48 (41.67%)  15/35 (42.86%) 
Stomatitis * 1  3/48 (6.25%)  1/35 (2.86%) 
Toothache * 1  0/48 (0.00%)  2/35 (5.71%) 
Vomiting * 1  10/48 (20.83%)  7/35 (20.00%) 
General disorders     
Asthenia * 1  3/48 (6.25%)  10/35 (28.57%) 
Axillary pain * 1  0/48 (0.00%)  2/35 (5.71%) 
Fatigue * 1  29/48 (60.42%)  8/35 (22.86%) 
Mucosal inflammation * 1  4/48 (8.33%)  2/35 (5.71%) 
Non-cardiac chest pain * 1  3/48 (6.25%)  0/35 (0.00%) 
Oedema peripheral * 1  1/48 (2.08%)  5/35 (14.29%) 
Pyrexia * 1  1/48 (2.08%)  4/35 (11.43%) 
Infections and infestations     
Gingivitis * 1  0/48 (0.00%)  2/35 (5.71%) 
Influenza * 1  3/48 (6.25%)  0/35 (0.00%) 
Lower respiratory tract infection * 1  3/48 (6.25%)  0/35 (0.00%) 
Nasopharyngitis * 1  9/48 (18.75%)  5/35 (14.29%) 
Pharyngitis * 1  0/48 (0.00%)  2/35 (5.71%) 
Rhinitis * 1  4/48 (8.33%)  1/35 (2.86%) 
Sinusitis * 1  1/48 (2.08%)  2/35 (5.71%) 
Upper respiratory tract infection * 1  3/48 (6.25%)  5/35 (14.29%) 
Investigations     
Alanine aminotransferase increased * 1  1/48 (2.08%)  3/35 (8.57%) 
Aspartate aminotransferase increased * 1  4/48 (8.33%)  2/35 (5.71%) 
Neutrophil count decreased * 1  5/48 (10.42%)  5/35 (14.29%) 
Platelet count decreased * 1  7/48 (14.58%)  5/35 (14.29%) 
Weight decreased * 1  3/48 (6.25%)  0/35 (0.00%) 
White blood cell count decreased * 1  3/48 (6.25%)  5/35 (14.29%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  11/48 (22.92%)  9/35 (25.71%) 
Hyperglycaemia * 1  2/48 (4.17%)  2/35 (5.71%) 
Hypomagnesaemia * 1  3/48 (6.25%)  0/35 (0.00%) 
Hyponatraemia * 1  1/48 (2.08%)  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  7/48 (14.58%)  7/35 (20.00%) 
Back pain * 1  11/48 (22.92%)  7/35 (20.00%) 
Bone pain * 1  0/48 (0.00%)  2/35 (5.71%) 
Muscle spasms * 1  4/48 (8.33%)  4/35 (11.43%) 
Musculoskeletal chest pain * 1  3/48 (6.25%)  2/35 (5.71%) 
Musculoskeletal pain * 1  1/48 (2.08%)  3/35 (8.57%) 
Neck pain * 1  0/48 (0.00%)  3/35 (8.57%) 
Pain in extremity * 1  2/48 (4.17%)  3/35 (8.57%) 
Nervous system disorders     
Dizziness * 1  6/48 (12.50%)  1/35 (2.86%) 
Dysgeusia * 1  1/48 (2.08%)  3/35 (8.57%) 
Headache * 1  9/48 (18.75%)  10/35 (28.57%) 
Neuralgia * 1  0/48 (0.00%)  2/35 (5.71%) 
Neuropathy peripheral * 1  2/48 (4.17%)  4/35 (11.43%) 
Psychiatric disorders     
Depression * 1  1/48 (2.08%)  2/35 (5.71%) 
Insomnia * 1  5/48 (10.42%)  3/35 (8.57%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  9/48 (18.75%)  6/35 (17.14%) 
Dyspnoea * 1  9/48 (18.75%)  9/35 (25.71%) 
Epistaxis * 1  2/48 (4.17%)  2/35 (5.71%) 
Nasal congestion * 1  1/48 (2.08%)  2/35 (5.71%) 
Pleural effusion * 1  1/48 (2.08%)  2/35 (5.71%) 
Rhinorrhoea * 1  0/48 (0.00%)  2/35 (5.71%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  11/48 (22.92%)  7/35 (20.00%) 
Dry skin * 1  1/48 (2.08%)  3/35 (8.57%) 
Erythema * 1  0/48 (0.00%)  3/35 (8.57%) 
Pruritus * 1  1/48 (2.08%)  3/35 (8.57%) 
Vascular disorders     
Hot flush * 1  3/48 (6.25%)  3/35 (8.57%) 
Lymphoedema * 1  3/48 (6.25%)  2/35 (5.71%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02034916     History of Changes
Other Study ID Numbers: 673-201
2013-003076-12 ( EudraCT Number )
C3441008 ( Other Identifier: Alias Study Number )
First Submitted: January 9, 2014
First Posted: January 14, 2014
Results First Submitted: September 1, 2017
Results First Posted: November 6, 2017
Last Update Posted: July 31, 2019