Onyx Pharmaceuticals




Development        
Onyx Pharmaceuticals

BREAST CANCER
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Breast Cancer

Bayer and Onyx are launching a broad breast cancer program. The trials that have commenced are highlighted below. For a more comprehensive list of Nexavar® (sorafenib) tablets clinical trials, please visit clinicaltrials.gov or call 1-866-738-3021.

For more information on each trial, click on the green study title.

Phase 2 Study of Nexavar in Combination with Paclitaxel Chemotherapy*
Study Design: Randomized, double-blind, placebo-controlled trial
Patients: Locally recurrent or metastatic HER2-neu negative breast cancer patients who have not previously received chemotherapy
Purpose: To determine the effectiveness of Nexavar plus Paclitaxel when compared to Paclitaxel treatment alone by assessing the difference in progression-free survival (PFS), as well as to evaluate other measures of efficacy and safety
Location: Multiple centers throughout the U.S. and India

Phase 2 Study of Nexavar in Combination with Gemcitabine Chemotherapy*
Study Design: Randomized, double-blind, placebo-controlled study
Patients: Locally advanced or metastatic HER2-neu negative breast cancer patients who have progressed during or after bevacizumab therapy
Purpose: To determine the effectiveness of Nexavar plus Gemcitabine when compared to Gemcitabine treatment alone by assessing the difference in progression-free survival (PFS), as well as to evaluate other measures of efficacy and safety
Location: Multiple centers throughout the U.S.

Phase 2 Study of Nexavar in Combination with Capecitabine Chemotherapy*
Study Design: Randomized, double-blind, placebo-controlled study
Patients: Locally advanced or metastatic HER2-neu negative breast cancer patients who have received no more than one prior chemotherapy for locally advanced or metastatic breast cancer.
Purpose: To determine the effectiveness of Nexavar plus Capecitabine when compared to Capecitabine treatment alone by assessing the difference in progression-free survival (PFS), as well as to evaluate other measures of efficacy and safety
Location: Spain, France, Brazil

Phase 2 Study of Nexavar in Combination with Docetaxel and/or Letrozole*
Study Design: Randomized, double-blind, placebo-controlled trial
Patients: Locally recurrent or metastatic HER2-neu negative breast cancer patients who have not previously received systemic therapy
Purpose: To determine the effectiveness of Nexavar plus docetaxel, Nexavar plus letrozole, or Nexavar plus docetaxel and letrozole, when compared to docetaxel and/or letrozole treatments alone. In addition, the study will evaluate other measures of efficacy and safety
Location: Italy, Germany, Russia, Poland

* Not a company-sponsored trial.



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