A Phase II Study of Exemestane with and without Enzalutamide in Women with Advanced Hormone Receptor-Positive Breast Cancer

Protocol
13-257
Full Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer that is Estrogen or Progesterone Receptor-Positive and HER2-Normal
Phase
II
Purpose

Aromatase inhibitors are drugs used in postmenopausal women to treat breast cancers that are fueled by estrogen. They interfere with the production of estrogen in the body. However, in some women, the breast cancer stops responding to these drugs. Exemestane is an example of an aromatase inhibitor.

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 assess the safety and effectiveness of giving enzalutamide in combination with exemestane in women with advanced breast cancer. Women will be randomly assigned to receive exemestane with either enzalutamide or a placebo. All drugs used in this study are 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 advanced breast cancer that is positive for estrogen receptors and/or progesterone receptors and produces normal levels of HER2.
  • Patients may have had up to one prior regimen of hormonal therapy and one prior regimen of chemotherapy for advanced breast cancer.
  • At least 4 weeks must have passed since any major surgery, 2 weeks since chemotherapy or hormonal therapy, and 1 week since completion of radiation therapy 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 age 18 and 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
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