OncoMatch/Clinical Trials/NCT06099769
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
Is NCT06099769 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Enzalutamide and Mifepristone for metastatic breast cancer.
Treatment: Enzalutamide · Mifepristone · TPC — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: AR overexpression (IHC ≥10% of cell nuclei immunoreactive)
Tumor must be AR positive. AR is considered positive by IHC if ≥10% of cell nuclei are immunoreactive.
Required: HER2 (ERBB2) negative (negative per ASCO/CAP guidelines)
HER2 negative per American Society of Clinical Oncology/College of American Pathologists guidelines
Allowed: ESR1 low expression (1-10%)
ER-low defined as: ER and PgR 1-10%
Allowed: PR (PGR) low expression (1-10%)
ER-low defined as: ER and PgR 1-10%
Allowed: ESR1 negative expression (<1%)
TNBC (ER/PgR <1%)
Allowed: PR (PGR) negative expression (<1%)
TNBC (ER/PgR <1%)
Allowed: PD-L1 (CD274) overexpression
Patients with PD-L1 positive breast cancer (CPS ≥ 10) should have received prior treatment with a checkpoint inhibitor setting unless there is a contraindication to checkpoint inhibitor therapy.
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: antiandrogen
Prior antiandrogen therapy (AR antagonist or CYP17 inhibitors).
Lab requirements
Blood counts
ANC ≥1000, hemoglobin ≥9 g/dL, platelets ≥100,000
Kidney function
creatinine ≤ 1.5x ULN
Liver function
Total bilirubin ≤1.5x ULN (except Gilbert syndrome); AST/ALT ≤3x ULN (≤5x ULN if liver metastases)
Adequate organ and marrow function, as defined below: * ANC ≥1000, hemoglobin ≥9 g/dL, platelets ≥100,000 * Total bilirubin ≤1.5x upper limit of normal (ULN), except for patients with known Gilbert syndrome; AST/ALT ≤3x ULN (≤5x ULN if liver metastases); creatinine ≤ 1.5x ULN. * Cortisol within normal limits
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- University of California San Francisco (Data collection only) · San Francisco, California
- University of Chicago Medical Center · Chicago, Illinois
- Dana Farber Cancer Institute (Data Collection Only) · Boston, Massachusetts
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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