Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced the full results from their first Phase 2 trial of Nexavar (sorafenib tablets) in combination with the oral chemotherapeutic agent, capecitabine for the treatment of advanced breast cancer. This randomized, double-blind, placebo-controlled study enrolled 229 patients with locally advanced or metastatic HER-2 negative breast cancer who had received no more than one prior chemotherapy. The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, time to progression, and safety. Positive results from this study showed that Nexavar in combination with capecitabine, significantly extended progression-free survival in patients with advanced breast cancer by 74 percent compared to those who received chemotherapy alone. The difference in median progression-free survival of Nexavar plus capecitabine versus capecitabine plus placebo was statistically significant, 6.4 months vs. 4.1 months (HR=0.576, p=0.0006).

Nexavar is a multikinase inhibitor indicated for the treatment of advanced renal cell carcinoma and unresectable hepatocellular carcinoma.

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