Status and phase
Conditions
Treatments
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Female or male
Pathologically confirmed invasive breast cancer that is unresectable, locally advanced, or metastatic
TNBC (ER/PgR <1%) or ER-low defined as:
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 1 prior line of chemotherapy for metastatic breast cancer.
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:
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.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
201 participants in 3 patient groups
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Central trial contact
Tiffany Traina, MD; Ayca Gucalp, MD
Data sourced from clinicaltrials.gov
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