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news.Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have released results from an investigational Phase III trial of sorafenib (Nexavar) tablets plus capecitabine in patients with advanced breast cancer.
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According to the companies, the Phase III trial called RESILIENCE failed to meet its primary endpoint of improving progression-free survival (PFS).
In the randomized, double-blind, placebo-controlled trial, the efficacy and safety of sorafenib was assessed in combination with capecitabine, an oral chemotherapeutic agent, compared to placebo plus capecitabine.
The trial was conducted in patients with HER2 negative breast cancer who are resistant to or have failed prior taxane, and are resistant to or have failed an anthracycline or for whom further anthracycline therapy is not indicated.
Around 537 patients from over 20 countries, including the US, Europe, Japan and Australia were enrolled in the trial.
Primary endpoint of the trial was progression-free survival, while secondary endpoints included overall survival, time to progression, overall response rate, disease control rate, duration of response, patient reported quality of life and safety.
In the trial, patients were given 600mg of oral sorafenib 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.