NCT06099769

A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	mouth once daily (160 mg/day)
DRUG	Mifepristone	mouth once daily 300-mg tablet
DRUG	TPC	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

Timeline

• Start date: 2023-10-18
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-10-25
• Last updated: 2026-02-25

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study