Phase 3 study of Nexavar for the treatment of breast cancer

Bayer and Onyx began enrollment of their Phase 3 study of Nexavar (sorafenibin) combination with capecitabine for the treatment of patients with advanced breast cancer. This trial is a randomized, double-blind, placebo-controlled study enrolling 519 patients in more than 20 countries. The study will evaluate Nexavar in combination with capecitabine in patients with locally advanced or metastatic HER-2 negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline is not indicated. The primary endpoint of the study is progression-free survival. Secondary endpoints include overall survival, time to progression, and safety.

Nexavar has been shown to inhibit members of two classes of kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. It is approved in the U.S. for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer.

For more information call (866) NEXAVAR or visit www.nexavar.com.