drugset / Trial / NCT06099769
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
Phase 2
Recruiting
201 enrolled
Memorial Sloan Kettering Cancer Center
Astellas Pharma US, Inc. · collabBreast Cancer Research Foundation · collabCorcept Therapeutics · collab
RandomizedCrossoverOpen-labelTreatment
Summary
The researchers are doing this study to find out if the study drug, enzalutamide, alone or combined with the study drug, mifepristone, is effective in treating advanced or metastatic androgen receptor-positive (AR+) triple negative breast cancer (TNBC) or estrogen receptor-low breast cancer (ER-low BC), and whether these study treatments work as well as standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin.
Timeline
- Start
- 2023-10-18
- Primary completion
- 2027-10
- Completion
- 2027-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Comparator | Carboplatin | Small molecule | 2 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Enzalutamide | Other / unclassified | 120 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Comparator | Eribulin | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | Mifepristone | Small molecule | 300 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |