Actively Recruiting
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-25
201
Participants Needed
12
Research Sites
206 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Astellas Pharma US, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Signed pre-screening informed consent to allow androgen receptor (AR) testing
- Female or male patients
- Pathologically confirmed invasive breast cancer that is unresectable, locally advanced, or metastatic
- Triple negative breast cancer (ER/PgR <1%) or estrogen receptor-low breast cancer (ER and PgR 1-10%)
- HER2 negative per clinical guidelines
- Tumor must be AR positive (≥10% immunoreactive nuclei by IHC)
- Evaluable or measurable disease per RECIST version 1.1
- Eligible for one chemotherapy option as chosen by investigator
- Availability of tumor tissue specimen for diagnosis and testing
- Up to 2 prior lines of chemotherapy for metastatic breast cancer allowed
- Any number of prior endocrine/targeted therapy lines allowed for ER-low breast cancer
- Prior checkpoint inhibitor treatment if PD-L1 positive unless contraindicated
- Patients may receive bisphosphonate or denosumab
- ECOG performance status 0-2
- Able to understand and willing to provide informed consent
- No other active malignancy requiring treatment
- Women of child-bearing potential and men must agree to use two forms of contraception during and for 7 months after treatment
- Women must not breastfeed during and at least 3 months after treatment
- Ability to swallow intact enzalutamide and mifepristone
- Recovered from recent major surgery; radiation completed at least 14 days prior
- Last chemotherapy or investigational therapy dose at least 14 days prior
- Adequate organ and marrow function as defined in the protocol
- Agreement to research biopsy at study entry unless medically infeasible
You will not qualify if you...
- History of seizure disorder or conditions increasing seizure risk
- History of brain metastases or leptomeningeal disease
- Prior antiandrogen therapy (AR antagonist or CYP17 inhibitors)
- Use of other concurrent investigational anticancer agents
- QTcF interval >480 msec
- Severe concurrent disease or infection interfering with study participation
- Pregnant patients
- Women with unexplained vaginal bleeding or endometrial hyperplasia or carcinoma
- Active gastrointestinal disorders affecting absorption
- Concurrent or chronic daily corticosteroid use (topical or inhaled corticosteroids allowed)
- Concurrent use of strong CYP3A4 inducers/inhibitors or substrates unless switched to alternatives
- Hypersensitivity to study drug ingredients including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
AI-Screening
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Trial Site Locations
Total: 12 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of California San Francisco (Data collection only)
San Francisco, California, United States, 94143
Actively Recruiting
3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
6
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
7
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
8
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
9
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
11
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
12
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
T
Tiffany Traina, MD
CONTACT
A
Ayca Gucalp, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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