A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patients With Stage II or Stage III Breast Cancer
The study combines bevacizumab with a very efficacious combination chemotherapy regimen for
the treatment of stage II or stage III primary breast cancer. Safety of the TAC-bevacizumab
combination will be evaluated. In addition, the study design incorporates an initial cycle
of bevacizumab or placebo alone. Assessing the isolated effects of bevacizumab in a setting
where pre- and post-treatment tissue specimens can be obtained will provide essential
information about the mechanisms by which VEGF inhibition affects tumor growth, and
represents an ideal opportunity to evaluate the molecular effects of bevacizumab on breast
tumor tissue.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
•To evaluate the safety and toxicity of the TAC regimen with the addition of bevacizumab given as preoperative therapy to patients with Stage II or Stage III breast cancer
Yes
Fairooz Kabbinavar, MD
Study Chair
Chief Medical Officer
United States: Food and Drug Administration
TORI B-02
NCT00203372
April 2005
Name | Location |
---|---|
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Northwest Georgia Oncology Centers, P.C. | Marietta, Georgia 30060 |
Cancer Institute of Florida, P.A. | Orlando, Florida 32804 |
South Texas Oncology and Hematology, P.A. | San Antonio, Texas 78207 |