A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of Talazoparib (BMN 673) Versus Physician's Choice in Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens for Metastatic Disease.
Primary Outcome Measures:
- Progression Free Survival (PFS)
Secondary Outcome Measures:
-Evaluate objective response rate (ORR)
-Evaluate overall survival (OS)
-Safety as assessed by percentage of patients with any Adverse Event (AE)
-Pharmacokinetics of talazoparib as assessed by trough plasma concentrations
Other Outcome Measures:
-Duration of response (DOR) for objective responders
-Health-related quality of life
-2 Validated questionnaires to assess general quality of life and deterioration due to breast cancer
The EMBRACA study compared the safety and effectiveness of the PARP inhibitor talazoparib to commonly used chemotherapy drugs in women and men with an inherited BRCA1 or BRCA2 mutation diagnosed with locally advanced or metastatic breast cancer. The researchers wanted to enroll 429 participants and used the Army of Women (AOW) as one of their recruitment sources. The Call to Action for this study was sent to AOW members on November 16, 2016. The researchers were able to close enrollment on April 25, 2017, after the AOW provided them with 6 volunteers who were interested in enrolling in the study.