A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
NCT ID: NCT06099769
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
201 participants
INTERVENTIONAL
2023-10-18
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Enzalutamide
Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle
Enzalutamide
mouth once daily (160 mg/day)
Enzalutamide with Mifepristone
Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle
Enzalutamide
mouth once daily (160 mg/day)
Mifepristone
mouth once daily 300-mg tablet
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.
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
Interventions
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Enzalutamide
mouth once daily (160 mg/day)
Mifepristone
mouth once daily 300-mg tablet
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
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years at time of consent
* signed the pre-screening informed consent document to allow for AR testing as part of study screening
Treatment Cohort:
* Female or male
* Pathologically confirmed invasive breast cancer that is unresectable, locally advanced, or metastatic
* TNBC (ER/PgR \<1%) or ER-low defined as:
* ER and PgR 1-10%
* HER2 negative per American Society of Clinical Oncology/College of American Pathologists guidelines
* Local testing for ER/PgR and HER2 is acceptable for eligibility.
* Tumor must be AR positive. AR is considered positive by IHC if ≥10% of cell nuclei are immunoreactive.
°AR testing performed locally must use protocol specified methodology to be acceptable for eligibility. Central testing is an option for those unable to perform local testing per this methodology. Please refer to the Section entitled "Treatment Plan" for AR testing methodology or refer to the laboratory manual.
* Evaluable or measurable disease per RECIST version 1.1; subjects with no evaluable AND no measurable disease (e.g., malignant effusions or bone marrow as the only manifestations of disease) are not eligible for enrollment.
* Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, paclitaxel, or carboplatin), as per investigator assessment.
* A representative, formalin-fixed, paraffin-embedded tumor specimen that enables the diagnosis of breast cancer, with adequate viable tumor cells in a tissue block (preferred) or 15 freshly cut unstained slides and 1 H\&E slide. Tissue from a metastatic site is preferred.
If not available, tissue from the primary site may be obtained.
* Patients may have received up to 2 prior lines of chemotherapy for metastatic breast cancer.
* Patients with ER-low breast cancer may receive any number of lines of endocrine therapy +/- targeted therapy (i.e., CDK4/6 inhibitors, PI3K inhibitors).
* 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.
* Patients may receive bisphosphonate or denosumab.
* ECOG performance status 0-2.
* Age ≥18 years.
* Able to understand and the willingness to provide informed consent.
* Patients must not have another active malignancy that requires treatment.
* Women of child-bearing potential and men must agree to use 2 forms of adequate contraception (i.e., barrier contraception, abstinence, intrauterine device, or sterilization method) during study period and for 7 months following treatment end. Women must not breast feed while on study and for at least 3 months after final drug administration.
* Ability to swallow intact enzalutamide and mifepristone.
* Patient must be recovered from any recent major surgery. Radiation must have completed 14 days prior to study start. If treated in the second-line setting, the last chemotherapy or investigational anticancer therapy dose must be at least 14 days prior.
* 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
* Patients must agree to research biopsy at study entry until 40 patients randomized to Arm A and 40 patients randomized to Arm B and 20 patients randomized to Arm C have been biopsied.
* Biopsy requirement may be waived in consultation with the study PI (Drs. Traina or Nanda) if not medically feasible.
Exclusion Criteria
* History of brain metastases or leptomeningeal disease.
* Prior antiandrogen therapy (AR antagonist or CYP17 inhibitors).
* Other concurrent investigational anticancer agents.
* Confirmed QT interval with Fridericia correction (QTcF) \> 480 msec.
* Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or that interferes with the patient's ability to participate in the study requirements.
* Pregnant patients are not eligible for study.
* Women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma are excluded from study.
* An active gastrointestinal disorder affecting absorption (e.g., gastrectomy, uncontrolled celiac disease).
* Use of concurrent or chronic daily corticosteroid use. Topical or inhaled corticosteroids are permitted.
* Use of concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4. Patients may be switched to alternative medications for eligibility purposes. A list of CYP3A4 substrates, inducers, and/or inhibitors
* Hypersensitivity reaction to the active pharmaceutical ingredient or any of the tablet components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
18 Years
ALL
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Breast Cancer Research Foundation
OTHER
Corcept Therapeutics
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Tiffany Traina, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Central Contacts
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Ayca Gucalp, MD
Role: CONTACT
Facility Contacts
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Katia Khoury, MD
Role: primary
Hope Rugo, MD
Role: primary
Rita Nanda, MD
Role: primary
Erica Mayer, MD, MPH
Role: primary
Tiffany Traina, MD
Role: primary
Tiffany Traina, MD
Role: primary
Tiffany Traina, MD
Role: primary
Tiffany Traina, MD
Role: primary
Tiffany Traina, MD
Role: primary
Tiffany Traina, MD
Role: primary
Ayca Gucalp, MD
Role: backup
Tiffany Traina, MD
Role: primary
Lisa Carey, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-334
Identifier Type: -
Identifier Source: org_study_id
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