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Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced that their first cooperative group–sponsored randomized Phase 2 trial in advanced metastatic breast cancer met its primary endpoint of progression–free survival. The study evaluated Nexavar tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER–2 negative breast cancer. Study findings demonstrated that the median progression–free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant. In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting.

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