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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06099769 | A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer | PHASE2 | RECRUITING | 201 | — | — | Oct 18, 2023 | Oct 1, 2027 | Feb 25, 2026 | 12 | United States |
Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) Committee (version 1.1).
| Arm | Type | Description |
|---|---|---|
| Enzalutamide | EXPERIMENTAL | Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle |
| Enzalutamide with Mifepristone | EXPERIMENTAL | Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle |
| Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC) | ACTIVE_COMPARATOR | The treating physician must select from one of the following regimens. * Eribulin 1.4 mg/m2 IV Day 1 and Day 8 in a 21-day cycle * Capecitabine 1000-1250 mg/m2 twice daily, orally Day 1-14 in a 21-day cycle * Paclitaxel 80 mg/m2 IV Day 1, Day 8 in a 21-day cycle * Carboplatin AUC 6 IV Day 1 in a 21-day cycle * Carboplatin AUC 2 IV Day 1, Day 8 and Day 15 in a 21-day cycle Patients randomized to TPC may be offered crossover to enzalutamide plus mifepristone treatment at the time of disease progression if they continue to meet eligibility criteria. |
| Name | Type | Description |
|---|---|---|
| Enzalutamide | DRUG | mouth once daily (160 mg/day) |
| Mifepristone | DRUG | mouth once daily 300-mg tablet |
| TPC | DRUG | The treating physician must select from one of the following regimens: * Eribulin 1.4 mg/m2 IV Day 1 and Day 8 in a 21-day cycle * Capecitabine 1000-1250 mg/m2 twice daily, orally Day 1-14 in a 21-day cycle * Paclitaxel 80 mg/m2 IV Day 1, Day 8 in a 21-day cycle * Carboplatin AUC 6 IV Day 1 in a 21-day cycle * Carboplatin AUC 2 IV Day 1, Day 8 and Day 15 in a 21-day cycle |
Inclusion Criteria: Screening Cohort (non-MSK patients only): * Age ≥18 years at time of consent * signed the pre-screening informed consent document to allow for AR testing as part of study screening Treatment Cohort: * Female or male * Pathologically confirmed invasive breast cancer that is un...