Medivation, Inc. and Astellas Pharma US Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma, announced the initiation of a Phase 2 clinical trial evaluating the safety and efficacy of enzalutamide in combination with exemestane in women with advanced breast cancer that is estrogen receptor positive (ER+) or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 (HER2) normal.
“The androgen receptor is expressed in the majority of patients with hormone receptor positive breast cancer,” said Lynn Seely, chief medical officer of Medivation. “Exemestane is a commonly used aromatase inhibitor in patients whose tumors express either the estrogen or progesterone receptor. It is our hope that inhibiting androgen receptor signaling with enzalutamide in combination with exemestane will provide benefit beyond the inhibition of estrogen and progesterone signaling in patients with advanced breast cancer.”
The Phase 2 study is a randomized, double-blind, placebo-controlled, multicenter trial of enzalutamide in combination with exemestane versus placebo plus exemestane in 240 postmenopausal women with advanced breast cancer that is ER+ or PgR+ and HER2 normal that have received no more than one prior chemotherapy and one prior hormonal treatment for their advanced disease.
The 240 patients will be assessed in two parallel cohorts of 120 patients each. The first cohort will enroll patients who have not previously received hormonal treatment for advanced breast cancer. The second cohort will enroll patients who have previously progressed following one hormonal treatment for advanced disease.
The primary endpoint of the trial is progression-free survival in all patients and in the subset of patients whose tumor expresses the androgen receptor.
Date: December 4, 2013
Source: Medivation
Filed Under: Drug Discovery
