A Phase I Study of Enzalutamide (MDV3100) in Patients with Previously Treated Metastatic Breast Cancer

Protocol
12-155
Full Title
A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide(Formerly MDV3100) in Patients with Incurable Breast Cancer
Phase
I
Purpose

Enzalutamide (MDV3100) is a drug that blocks the hormone testosterone from binding to the androgen (male hormone) receptor. It is approved for the treatment of men with advanced prostate cancer. Researchers believe that blocking the androgen receptor may also slow or stop tumor growth in patients with breast cancer.

The purpose of this study is to determine the highest dose of enzalutamide that can be given safely in women with metastatic breast cancer that persists despite prior treatment. The use of enzalutamide in breast cancer patients is considered investigational. Enzalutamide is a capsule that is taken orally (by mouth).

Eligibility

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

  • Patients must have metastatic breast cancer that continues to grow despite at least two regimens of systemic therapy for advanced disease.
  • Patients must have recovered from the serious side effects of prior therapies.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

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

Disease(s)
Breast Cancer
Locations
Related Diseases