Nexavar fails to meet primary endpoint in HER-2–negative breast cancer

  • July 25, 2014

Results from a phase 3 trial have found that sorafenib plus capecitabine did not meet its primary endpoint of improving PFS for the treatment of locally advanced or metastatic HER-2–negative breast cancer, manufacturers Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals reported.

The phase 3, double-blind, placebo-controlled study – RESILIENCE – evaluated sorafenib (Nexavar, Bayer) in combination with capecitabine (Xeloda, Hoffmann-La Roche) in 537 patients with patients with locally advanced or metastatic 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.

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