Clinical Trials in Breast Cancer

Bayer and Onyx have launched a broad breast cancer program. For a more comprehensive list of Nexavar® (sorafenib) clinical trials, please visit clinicaltrials.gov or call 1-866-738-3021.
 

Phase 2 Study of Nexavar in Combination with Capecitabine Chemotherapy *

Complete data analysis presented at the ECCO/ESMO Oncology Congress

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

Sponsor:  Collaborative study conducted in sponsorship with SOLTI (Grupo Espanol de Estudio, Tratamiento y otras Estrategias Experimentales en Tumores Solidos), a not-for-profit scientific organization, is a network of high-level oncology services primarily located in Spain and Portugal.  Their commitment is to excellence in oncology trials that are designed to answer important questions about potential new oncology agents.

Phase 2 Study of Nexavar in Combination with Paclitaxel Chemotherapy *

Complete data analysis to be presented at an upcoming scientific meeting

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 United States and India
 

Phase 2 Study of Nexavar in Combination with Gemcitabine or Capecitabine *

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 or 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: Multiple centers throughout the United States
 

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.