Trials / Completed
CompletedNCT01945775
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 431 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | talazoparib | Until progression or unacceptable toxicity develops |
| DRUG | Physician's-Choice | Capecitabine, Eribulin, Gemcitabine or Vinorelbine |
Timeline
- Start date
- 2013-10-14
- Primary completion
- 2017-09-15
- Completion
- 2021-03-05
- First posted
- 2013-09-19
- Last updated
- 2022-01-20
- Results posted
- 2018-10-03
Locations
362 sites across 16 countries: United States, Australia, Belgium, Brazil, France, Germany, Ireland, Israel, Italy, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01945775. Inclusion in this directory is not an endorsement.