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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00938652 | A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer | PHASE3 | COMPLETED | 519 | — | — | Jul 1, 2009 | Feb 1, 2012 | Sep 19, 2013 | 102 | United States |
| NCT00540358 | A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer | PHASE2 | COMPLETED | 123 | — | — | Oct 1, 2007 | Jun 1, 2010 | Dec 28, 2012 | 18 | United States |
Progression free survival was defined as the time interval from the date of randomization to the date of first disease progression (as assessed by Independent Radiologic Review (IRR) based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria), or the date of death due to any cause, whichever occurred first. In the absence disease progression or death, the participant was censored at the date of the last valid tumor assessment performed before the cut-off date.
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, participant was censored at the last date he/she was known to be alive, or at the cut-off date, whichever was earlier.
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
| Arm | Type | Description |
|---|---|---|
| Arm G/C | ACTIVE_COMPARATOR | gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s) |
| Arm G/C/I | EXPERIMENTAL | gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s) |
| Name | Type | Description |
|---|---|---|
| gemcitabine/carboplatin | DRUG | Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes) Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes) |
| Iniparib | DRUG | Body weight adjusted dose intravenous infusion (60 ± 10 minutes) |
Inclusion Criteria: \- Histologically documented breast cancer (either primary or metastatic site) that is ER-negative, PR-negative, and HER2 non-overexpressing by immunohistochemistry (0, 1) or fluorescence in situ hybridization (FISH). Triple-negative tumors were defined by the following criteri...