NCT06099769

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for phase_2

Timeline
17mo left

Started Oct 2023

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Oct 2023Oct 2027

Study Start

First participant enrolled

October 18, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

October 19, 2023

Last Update Submit

February 24, 2026

Conditions

Metastatic Breast Cancer

Keywords

EnzalutamideMifepristoneCarboplatinPaclitaxelCapecitabineEribulinTriple-negativeAndrogen receptor positive22-334

Outcome Measures

Primary Outcomes (1)

  • progression-free survival (PFS)

    Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) Committee (version 1.1).

    2 years

Study Arms (3)

Enzalutamide

EXPERIMENTAL

Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle

Drug: Enzalutamide

Enzalutamide with Mifepristone

EXPERIMENTAL

Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle

Drug: EnzalutamideDrug: Mifepristone

Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC)

ACTIVE COMPARATOR

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.

Drug: TPC

Interventions

EnzalutamideDRUG

mouth once daily (160 mg/day)

EnzalutamideEnzalutamide with Mifepristone
MifepristoneDRUG

mouth once daily 300-mg tablet

Enzalutamide with Mifepristone
TPCDRUG

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

Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screening Cohort (non-MSK patients only):
  • 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.
  • +18 more criteria

You may not qualify if:

  • Seizure disorder or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of California San Francisco (Data collection only)

San Francisco, California, 94143, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, 02115, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

enzalutamideMifepristone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tiffany Traina, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Traina, MD

CONTACT

646-888-4558trainat@mskcc.org

Ayca Gucalp, MD

CONTACT

646-888-4536

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This phase II study will randomize.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 25, 2023

Study Start

October 18, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(12)