RecruitingPhase 2NCT06099769

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

201 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether enzalutamide (a hormone-targeting drug) — alone or combined with mifepristone — can treat a specific type of metastatic breast cancer (triple-negative or low-estrogen breast cancer) that tests positive for androgen receptors (AR-positive). The study also compares this to standard chemotherapy options. **You may be eligible if...** - You are 18 years or older (male or female) - You have confirmed advanced or metastatic breast cancer that is triple-negative (ER/PR negative) or has very low estrogen receptor expression (1–10%) - Your tumor is HER2-negative - Your tumor tests positive for androgen receptors (AR-positive, at least 10%) - You have measurable or evaluable disease on imaging - You have previously received at least one treatment for advanced/metastatic disease - You are eligible for at least one standard chemotherapy option **You may NOT be eligible if...** - Your tumor is HER2-positive - Your tumor does not have androgen receptors - You have no measurable disease on imaging (e.g., only bone marrow or fluid involvement) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnzalutamide

mouth once daily (160 mg/day)

DRUGMifepristone

mouth once daily 300-mg tablet

DRUGTPC

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


Locations(12)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California San Francisco (Data collection only)

San Francisco, California, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06099769


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