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

Conditions

• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enzalutamide — DRUG
  mouth once daily (160 mg/day)
• Mifepristone — DRUG
  mouth once daily 300-mg tablet
• TPC — DRUG
  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

Study Details

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.

Key Dates

Start date

Oct 18, 2023

Status verified

Feb 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

201 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Enzalutamide
  Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle
• Experimental: Enzalutamide with Mifepristone
  Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle
• Active Comparator: Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (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 Patients randomized to TPC may be offered crossover to enzalutamide plus mifepristone treatment at the time of disease progression if they continue to meet eligibility criteria.

Primary Outcome Measure

progression-free survival (PFS) [ Time Frame: 2 years ]

Central Contacts

• Tiffany Traina, MD
  646-888-4558
  [email protected]
• Ayca Gucalp, MD
  646-888-4536

Locations (12)

Find similar trials in Birmingham, AL

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