A Phase 2 Study of Enzalutamide, Enzalutamide Plus Mifepristone, or Chemotherapy in People with Metastatic Breast Cancer


Full 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


In this study, researchers want to see if enzalutamide, alone or with mifepristone, works well against advanced breast cancer. The people in this study have either triple-negative breast cancer (TNBC) or cancer that is low in estrogen receptors (ER). Receptors are docking sites on cancer cells for hormones or other proteins. TNBC is breast cancer that is not fueled by estrogen or progesterone and does not make a protein called HER2. The people in this study also have cancer cells that have receptors for proteins called androgens (AR-positive cancers).

Enzalutamide may work well in these patients because it targets cells with AR. Another protein, glucocorticoid receptor (GR), helps keep cancer cells alive and may work with AR to boost cancer growth. Combining mifepristone with enzalutamide may be an effective treatment because mifepristone blocks GR activity.

If you join this study, you will be randomly assigned to receive one of these treatments:

  • Enzalutamide alone
  • Enzalutamide with mifepristone
  • Standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin

Who Can Join

To join this study, there are a few conditions. You must:

  • Have AR-positive TNBC or ER-low breast cancer that has spread despite treatment or cannot be surgically removed.
  • Have finished prior breast cancer treatment at least 2 weeks before getting the study therapy.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.


For more information or to see if you can join this study, please call Dr. Tiffany A. Traina’s office  at 646-888-4558.




Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory




ClinicalTrials.gov ID