At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 431 enrolled
Drug / intervention
talazoparib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating talazoparib and Physician's-Choice for Breast Neoplasms and 2 related conditions. Completed, enrolled 431 participants across 362 sites in 16 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
CountriesAustralia, Belgium, Brazil, France, Germany, Ireland, Israel, Italy, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsMedivation, Inc.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionSep 2017
Study CompletionMar 2021
TodayJul 2026
First PostedSep 19, 2013
Enrollment StartOct 14, 2013
Primary CompletionSep 15, 2017
Study CompletionMar 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.8 years ago
Interventions
talazoparibdrug
Until progression or unacceptable toxicity develops
Physician's-Choicedrug
Capecitabine, Eribulin, Gemcitabine or Vinorelbine