A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 unresectable, locally advanced, or metastatic * TNBC (ER/PgR \<1%) or ER-low defined as: * ER and PgR 1-10% * HER2 negative per American Society of Clinical Oncology/College of American Pathologists guidelines * Local testing for ER/PgR and HER2 is acceptable for eligibility. * Tumor must be…