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Hormone Therapy
Enzalutamide + Mifepristone or Chemotherapy for Breast Cancer
Phase 2
Recruiting
Led By Tiffany Traina, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A representative, formalin-fixed, paraffin-embedded tumor specimen that enables the diagnosis of breast cancer, with adequate viable tumor cells in a tissue block or 15 freshly cut unstained slides and 1 H&E slide
Patients with PD-L1 positive breast cancer (CPS ≥ 10) should have received prior treatment with pembrolizumab in combination with chemotherapy in the first line setting unless there is a contraindication to checkpoint inhibitor therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying if two drugs can effectively treat advanced triple negative or ER-low breast cancer, compared to standard chemotherapy.
Who is the study for?
This trial is for adults with advanced breast cancer that's spread and tests positive for certain receptors. They can have had one chemo treatment before, but not specific other treatments or conditions like brain metastases. Participants need to be able to take pills, have no severe diseases that could interfere, and agree to use two forms of birth control.Check my eligibility
What is being tested?
The study compares the effectiveness of Enzalutamide alone or combined with Mifepristone against standard chemotherapies (carboplatin, paclitaxel, capecitabine, eribulin) in treating advanced receptor-positive breast cancers. It aims to determine which method works best.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, skin rash from Enzalutamide; weight changes and abdominal pain from Mifepristone; hair loss and nerve damage from chemotherapy drugs like paclitaxel.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a breast cancer tissue sample for testing.
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I have PD-L1 positive breast cancer and was treated with pembrolizumab and chemotherapy, unless I couldn't tolerate checkpoint inhibitors.
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I am 18 years old or older.
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I can swallow pills without any issues.
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I am eligible for chemotherapy with eribulin, capecitabine, paclitaxel, or carboplatin.
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My tumor is androgen receptor positive.
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I can take care of myself and perform daily activities.
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I do not have any other cancer that needs treatment.
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My breast cancer cannot be surgically removed and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
progression-free survival (PFS)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Enzalutamide with MifepristoneExperimental Treatment2 Interventions
Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle
Group II: EnzalutamideExperimental Treatment1 Intervention
Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle
Group III: Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mifepristone
2013
Completed Phase 4
~3080
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
Corcept TherapeuticsIndustry Sponsor
68 Previous Clinical Trials
6,200 Total Patients Enrolled
1 Trials studying Breast Cancer
37 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,691 Total Patients Enrolled
203 Trials studying Breast Cancer
80,973 Patients Enrolled for Breast Cancer
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,632 Total Patients Enrolled
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