A Phase II Study of Enzalutamide in Women with Triple-Negative Breast Cancer that Contains the Androgen Receptor

Full Title
A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple-Negative Breast Cancer

Triple-negative breast cancers do not express the HER2 protein nor contain estrogen or progesterone receptors. They can be challenging to treat. Doctors are therefore seeking more effective therapies for this disease.

Scientists at Memorial Sloan-Kettering Cancer Center have found a subset of triple-negative breast cancers that act like estrogen-sensitive breast cancers and contain a protein called the androgen receptor. Studies have shown that blocking hormones called androgens slows the growth of breast cancer cells that lack estrogen and progesterone receptors but contain the androgen receptor.

Researchers believe that blocking the androgen receptor may slow or stop tumor growth in patients with breast cancer. The purpose of this study is to evaluate the safety and effectiveness of the drug enzalutamide in patients with advanced triple-negative breast cancer that contains the androgen receptor. Enzalutamide blocks testosterone from binding to the androgen receptor. It is approved for the treatment of men with advanced prostate cancer.

Enzalutamide is a pill that is taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced or metastatic triple-negative breast cancer that is positive for the androgen receptor.
  • At least 2 weeks must have passed since the last dose of chemotherapy and 4 weeks since any major surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients ages 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-5209.

Breast Cancer
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