A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
NCT ID: NCT01945775 Phase: PHASE3 Status: COMPLETED Enrollment: 431 Completion: 2021-03-05
Conditions
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Interventions
talazoparib, Physician's-Choice
Summary
The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.
Primary Outcome
Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment