Metastatic Breast CancerPhase 2NCT06099769
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
A Phase 2 study testing Enzalutamide, Mifepristone and TPC in people with Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Enzalutamide, Mifepristone and TPC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 12 sitesUnited States
- Study dates
- 18 Oct 2023to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ayca Gucalp, MD contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Tiffany Traina, MD, 646-888-4558
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Katia Khoury, MD, 205-801-9034
- Recruiting
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, 02115
Erica Mayer, MD, MPH, 617-632-3800
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27514
Lisa Carey, MD, 919-843-6814
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Rita Nanda, MD, 773-834-2756
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Tiffany Traina, MD, 646-888-4558
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Tiffany Traina, MD, 646-888-4558
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Tiffany Traina, MD, 646-888-4558
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Tiffany Traina, MD, 646-888-4558
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Tiffany Traina, MD, 646-888-4558
Ayca Gucalp, MD, 646-888-4536
- Recruiting
University of California San Francisco (Data collection only)
San Francisco, California, 94143
Hope Rugo, MD, 415-353-7070
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Tiffany Traina, MD, 646-888-4558
About this study
Official title: 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
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
- Metastatic Breast Cancer
- Being tested
- Enzalutamide, Mifepristone, TPC
- Keywords
- Enzalutamide, Mifepristone, Carboplatin, Paclitaxel, Capecitabine, Eribulin, Triple-negative, Androgen receptor positive, 22-334
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
mouth once daily (160 mg/day)
MifepristoneDrug
mouth once daily 300-mg tablet
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
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Experimental | Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle Receives: Drug: Enzalutamide |
| Enzalutamide with Mifepristone | Experimental | Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle Receives: Drug: Enzalutamide; Drug: 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. Receives: Drug: TPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start18 Oct 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This phase II study will randomize.
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc., Breast Cancer Research Foundation, Corcept Therapeutics
- Responsible party
- Sponsor
- Investigators
- Tiffany Traina, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099769
- Sponsor's protocol ID
- 22-334
- Status last verified
- Feb 2026
- First submitted
- 19 Oct 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06099769
- Acronym / sponsor ID
- 22-334
- Conditions
- Metastatic Breast Cancer
- Keywords
- Enzalutamide, Mifepristone, Carboplatin, Paclitaxel, Capecitabine, Eribulin, Triple-negative, Androgen receptor positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc., Breast Cancer Research Foundation, Corcept Therapeutics
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This phase II study will randomize.
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | Experimental | Drug: EnzalutamideEnzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle |
| Enzalutamide with Mifepristone | Experimental | Drug: Enzalutamide, Drug: MifepristoneEnzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle |
| Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC) | Active comparator | Drug: TPCThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Age ≥18 years at time of consent
- signed the pre-screening informed consent document to allow for AR testing as part of study screening
- Female or male
- Pathologically confirmed invasive breast cancer that is unresectable, locally advanced, or metastatic
- TNBC (ER/PgR \<1%) or ER-low defined as:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzalutamidemouth once daily (160 mg/day) | Drug | Enzalutamide, Enzalutamide with Mifepristone |
| Mifepristonemouth once daily 300-mg tablet | Drug | Enzalutamide with Mifepristone |
| TPCThe 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 | Drug | Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC) |
Primary outcome
progression-free survival (PFS)
Time frame: 2 years
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayca Gucalp, MD contact
Tiffany Traina, MD principal investigator
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide, Mifepristone and TPC in people with Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Traina, MD (646-888-4558, trainat@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.