Enzalutamide + Mifepristone or Chemotherapy for Breast Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot use certain medications that affect the CYP3A4 enzyme. You may need to switch to alternative medications if yours are strong inducers, inhibitors, or substrates of CYP3A4.
What data supports the effectiveness of the drugs used in the Enzalutamide + Mifepristone or Chemotherapy for Breast Cancer trial?
Research shows that capecitabine, a drug used in the trial, is effective and well-tolerated in treating metastatic breast cancer, and it may offer benefits when used early in the disease. Additionally, eribulin has been shown to improve survival in patients with previously treated metastatic breast cancer.12345
Is Enzalutamide generally safe for humans?
How is the drug combination of Enzalutamide and Mifepristone unique for breast cancer treatment?
This treatment is unique because it combines Enzalutamide, an androgen receptor blocker, with Mifepristone, which is known for its use in other conditions like abortion and Cushing's syndrome, to target breast cancer. This combination is novel as it explores the potential of androgen receptor inhibition in breast cancer, which is different from traditional chemotherapy approaches.611121314
Research Team
Tiffany Traina, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either enzalutamide, enzalutamide with mifepristone, or chemotherapy in a 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Crossover
Participants on chemotherapy may crossover to enzalutamide plus mifepristone upon disease progression
Treatment Details
Interventions
- Enzalutamide
- Mifepristone
- TPC
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Corcept Therapeutics
Industry Sponsor
Dr. Joseph K. Belanoff
Corcept Therapeutics
Chief Executive Officer since 2014
MD from Stanford University
Dr. William Guyer
Corcept Therapeutics
Chief Medical Officer since 2021
PharmD
Astellas Pharma US, Inc.
Industry Sponsor
Naoki Okamura
Astellas Pharma US, Inc.
Chief Executive Officer since 2023
Not available
Tadaaki Taniguchi
Astellas Pharma US, Inc.
Chief Medical Officer since 2023
MD, PhD
Breast Cancer Research Foundation
Collaborator