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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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Related medicine technology :

1. Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial
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3. Nexavar First FDA-Approved Drug Therapy for Liver Cancer
4. Nexavar Significantly Improves Overall Survival by 47 Percent in Asia-Pacific Liver Cancer Study
5. New Nexavar Data Presented in Multiple Tumor Types at 44th American Society of Clinical Oncology Annual Meeting
6. The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
7. Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
8. Phase 3 Trial of Nexavar in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint
9. Bayer and Onyx Announce Nexavar Data Presentations at 60th American Association for the Study of Liver Diseases Annual Meeting
10. Nexavar in Combination With Chemotherapy Demonstrates Activity in Patients With Advanced Breast Cancer in Two Phase 2 Studies
11. Phase 3 Trial of Nexavar in First-Line Advanced Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint of Overall Survival
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