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New treatment option for Metastatic Breast Cancer
Official title A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06099769
What this study is testing
What is Enzalutamide?
Enzalutamide is an investigational medicine, given as an once-daily, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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 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...
See the full eligibility criteria
- 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...
- Evaluable or measurable disease per RECIST version 1.1; people 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...
- 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...
- 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...
- 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 assigned by chance to Arm A and 40 patients assigned by chance to Arm B and 20 patients assigned by chance 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.
- 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...
- 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...
- 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...
- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the tablet components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Francisco, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.