Nexavar® (sorafenib) tablets will enter Phase III for treatment of advanced breast cancer in combination with capecitabine.
Bayer HealthCare and Onyx Pharmaceuticals, Inc. initiated the Phase III randomized, double-blind, placebo-controlled trial based on equivalent Phase II results.
The latest study will look at the treatment of locally advanced or metastatic, human epidermal growth factor receptor-2 (HER-2) negative breast cancer, using sorafenib in combination with capecitabine.
“This Phase III trial is an important milestone in our development of Nexavar as it provides an opportunity to validate the promising Phase II results,” said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare.
“We look forward to continuing our breast cancer clinical trial programme, which includes support of two ongoing cooperative group-sponsored Phase II trials, to gain additional understanding of how Nexavar may play a role in the advanced breast cancer treatment paradigm.”
The trial name RESILIENCE is an acronym for Phase III TRial Comparing CapecitabinE in Combination with SorafenIb or PLacebo for Treatment of Locally Advanced or MetastatIc HER2-Negative Breast CancEr.
It is a randomized, double-blind, placebo-controlled Phase III study planned to enroll 519 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.
Patients will receive 600 mg of oral Nexavar or matching placebo daily on a continuous schedule, in addition to 1000mg/m2 of capecitabine twice daily for 14 days of a 21 day cycle.
Dose escalation to 800 mg of oral Nexavar daily and capecitabine 1250 mg/m2 twice daily will be permitted depending on tolerance.
“Nexavar has demonstrated efficacy in advanced kidney cancer and unresectable liver cancer, and Bayer and Onyx are hopeful that this Phase III trial will lead to a new treatment option for patients with advanced breast cancer,” said Ted W. Love, M.D., Executive Vice President and Head of Research and Development for Onyx Pharmaceuticals.
“We are committed to evaluating Nexavar’s full potential in a variety of treatment settings and tumor types.”
Copyright Bayer Healthcare 2011