Thursday, June 27, 2013

Astellas and Medviation initate Phase 2 studies on Xtandi to evaluate efficacy in breast cancer

Medivation, Inc. and Astellas Pharma Inc. today announced enrollment of the first patient in a global Phase 2 clinical trial evaluating enzalutamide as a single agent for the treatment of advanced, androgen receptor (AR)-positive, triple-negative breast cancer (TNBC). The Phase 2 open label, single-arm, multicenter trial plans to enroll approximately 80 patients with AR-positive, TNBC at sites in the United States, Canada and Europe. The primary endpoint of the trial is clinical benefit rate, defined as the proportion of patients with a best response of complete response, partial response or stable disease at ≥ 16 weeks.  All patients will receive enzalutamide at a dose of 160 mg to be taken orally once daily.

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