Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
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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
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Study Type | Interventional |
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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 |
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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 | |
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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). |
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Overall Number of Baseline Participants | 61 | |
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Baseline analysis population included all participants who received any amount of talazoparib.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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%
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45-64 Years |
18 29.5%
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>=65 Years |
6 9.8%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 61 participants | |
Female |
61 100.0%
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Male |
0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 61 participants |
White |
47 77.0%
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Black or African American |
7 11.5%
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Asian |
3 4.9%
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Not reported |
4 6.6%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 61 participants |
Chinese |
1 1.6%
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African American |
7 11.5%
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Ashkenazi Jew |
1 1.6%
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Other |
49 80.3%
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Not reported |
3 4.9%
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Number of Participants with Triple Negative Breast Cancer (TNBC) at Baseline
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 61 participants | |
61 100.0%
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[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.
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Duration of Breast Cancer at Baseline
[1] Median (Full Range) Unit of measure: Weeks |
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Number Analyzed | 61 participants | |
3.57
(0.43 to 21.14)
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[1]
Measure Description: Duration (since onset) was defined as time (weeks) from histopathological (primary) diagnosis until study entry (baseline).
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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%
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BRCA2 |
13 21.3%
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[1]
Measure Description: Participants with BRCA1/2 mutations at baseline were defined as participants with positive Myriad BRCA1/2 laboratory test results at baseline.
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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 |
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 |