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Nexavar in Combination with Chemotherapy Improves Progression-Free Survival in Patients with Advanced Breast Cancer in Phase 2 Study
Date:5/18/2011

a company-sponsored, randomized, double-blind, placebo-controlled Phase 3 study planned to enroll approximately 500 patients in more than 20 countries, including the United States, Brazil, Japan and Australia. 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.

About the Nexavar Clinical Program in Breast Cancer

This study is part of a company-supported clinical development program known as TIES (Trials to Investigate the Effects of Sorafenib in Breast Cancer), where sorafenib is being evaluated in four investigator/cooperative group-sponsored Phase 2 trials for patients with advanced breast cancer and in a variety of treatment settings. The remaining ongoing trial under this program is evaluating sorafenib plus docetaxel and/or letrozole in the first-line setting.

About Breast Cancer

Breast cancer was the most commonly diagnosed cancer among women worldwide in 2007-2008 (approximately 1.3 million cases), and the second leading cause of cancer-related death among women (approximately 465,000 deaths). It is the most commonly diagnosed cancer among women in the United States (1 in 4 cancer diagnoses is breast cancer). There are approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year. More than 40,000 women in the United States and more than 130,000 in Europe die of breast cancer each year. (l)(ll)(lll)

About Nexavar

Nexavar 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. Nexava
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
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