Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01945775 | A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) | PHASE3 | COMPLETED | 431 | — | — | Oct 14, 2013 | Mar 5, 2021 | Jan 20, 2022 | 362 | United States, Australia +14 |
IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| talazoparib | EXPERIMENTAL | Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days |
| Physician's-Choice | ACTIVE_COMPARATOR | Capecitabine, Eribulin, Gemcitabine or Vinorelbine |
| Name | Type | Description |
|---|---|---|
| talazoparib | DRUG | Until progression or unacceptable toxicity develops |
| Physician's-Choice | DRUG | Capecitabine, Eribulin, Gemcitabine or Vinorelbine |
Inclusion Criteria: * Histologically or cytologically confirmed carcinoma of the breast * Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy * Documentation of a deleterious, sus...