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Nexavar in Combination with Chemotherapy Shown to Extend Progression-Free Survival in Patients with Advanced Breast Cancer
Date:7/22/2009

'Hebron Institute of Oncology in Barcelona and the principal investigator of this study. "One goal of this study was to evaluate the success of an all-oral regimen, which may represent a unique treatment option for patients with breast cancer."

Breast Cancer Trial Design

The randomized, double-blind, placebo-controlled Phase 2 study evaluated Nexavar in combination with the oral chemotherapeutic agent, capecitabine, in 229 patients. These patients had locally advanced or metastatic HER-2 negative breast cancer and had received no more than one prior chemotherapy in this setting. The primary endpoint of the study was progression-free survival. There were several secondary endpoints, including overall survival, time to progression, and safety. Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to 1000 mg/m(2) of capecitabine twice daily for 14 days followed by a seven day rest from capecitabine.

About the Nexavar Clinical Program in Breast Cancer

Nexavar is being evaluated in collaboration with investigators and cooperative groups in a variety of treatment settings for patients with breast cancer. Among these trials are three ongoing randomized Phase 2 studies, including a trial to evaluate Nexavar plus paclitaxel in the first-line setting, a trial to evaluate Nexavar plus gemcitabine or capecitabine in the first- or second-line setting following progression on bevacizumab, and a trial to evaluate Nexavar 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 leading cause of death among women with cancer (approximately 465,000 deaths). It is the most commonly diagnosed cancer among women in the United States (1 in 4 cancer diagnoses is breast ca
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SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.
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