A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: Memorial Sloan Kettering Cancer Center
You may qualify if…
- ✓ 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%
You may not qualify if…
- ✕ Seizure disorder or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months.
- ✕ History of brain metastases or leptomeningeal disease.
- ✕ Prior antiandrogen therapy (AR antagonist or CYP17 inhibitors).
- ✕ Other concurrent investigational anticancer agents.
- ✕ Confirmed QT interval with Fridericia correction (QTcF) \> 480 msec.
- ✕ Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or that interferes with the patient's ability to participate in the study requirements.
- ✕ Pregnant patients are not eligible for study.
- ✕ Women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma are excluded from study.
Where it's recruiting
Birmingham
San Francisco
Chicago
Boston
Basking Ridge · Middletown · Montvale
Commack · Harrison · New York · Uniondale
Chapel Hill
Source: ClinicalTrials.gov · NCT06099769 · last updated 2026-02-25