Astellas and Medivation prepare for clinical study | Courtesy of Shutterstock
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Amanda Rupp | Jun 5, 2016

Astellas, Medivation launch triple-negative breast cancer trial for enzalutamide

Astellas Pharma Inc. and Medivation Inc. recently announced that it will initiate its new phase-three clinical trial to evaluate the safety and efficacy of enzalutamide for treating patients who have triple-negative breast cancer (TNBC).

This study is extremely important, as an estimated 246,000 women received new diagnoses of breast cancer in 2016 alone. Another 40,000 women are expected to die from the disease this year.

The Endear study is a phase-three, randomized international study that will compare enzalutamide with PaclitaxEl Chemotherapy. The study will also compare a monotherapy with a placebo that includes Paclitaxel. The qualifying patients all have advanced, diagnostic-positive, triple-negative breast cancer.

"Our initiation of this trial represents our commitment to explore the potential of enzalutamide in patients with advanced TNBC," Mohammad Hirmand, interim chief medical officer of Medivation, said.

Medivation will lead the trial. It will start enrolling patients during the fourth quarter of this year. All of the patients must have locally advanced or metastatic TNBC with tumors that test positive for a new gene expression profile.

"The initiation of the Endear trial reflects our ongoing commitment to investigate the full clinical utility of enzalutamide," Claire Thom, senior vice president and oncology therapeutic area head, Astellas, said.

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