Onyx Pharmaceuticals




Clinical 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

Phase 2 Study of Nexavar in Combination with Letrozole, Anastrozole, or Exemestane*
Study Design:
Randomized, double-blind, placebo-controlled study
Patients: Metastatic HER2-neu negative, postmenopausal breast cancer patients who have not previously received systemic therapy
Purpose: To determine the effectiveness of Nexavar plus letrozole, anastrozole, or exemestane when compared to letrozole, anastrozole, or exemestane treatments alone. In addition, the study will evaluate other measures of efficacy and safety
Location: U.S.

* Not a company-sponsored trial.



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©2008 Onyx Pharmaceuticals, Inc.