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news.Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have started patient recruitment in a randomized, double-blind, placebo-controlled Phase 3 Nexavar (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, versus placebo plus capecitabine for the treatment of patients with advanced breast cancer.
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The Phase 3 trial was supported by the results from a cooperative group-sponsored Phase 2 clinical trial evaluating Nexavar in combination with capecitabine in patients with advanced breast cancer.
The primary endpoint of the study is progression-free survival.
The secondary endpoints include overall survival, time to progression and safety.
Onyx Pharma Research and Development and Technical Operations head and executive vice president Love said Nexavar has demonstrated efficacy in advanced kidney cancer and unresectable liver cancer and we are committed to evaluating Nexavar in a variety of treatment settings and tumor types.