The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and investigate whether changes in gene expression, or the expression of specific biomarkers, are either predictive of response to bevacizumab or indicative of response.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).
placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC
one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.
UCLA Medical Center
Los Angeles, California, United States
Wilshire Oncology Medical Group, Inc.
Pomona, California, United States
Cancer Institute of Florida, P.A.
Orlando, Florida, United States
Northwest Georgia Oncology Centers, P.C.
•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
Patients will be evaluated for adverse events (all grades) at each study visit for the duration of their participation in the study. All AEs should be graded using the NCI--CTCAE, Version 3.0. Patients discontinued from the treatment phase of the study for any reason will be evaluated within 30 days after the decision to discontinue treatment.
Time frame: 4 years
•To estimate change from baseline expression of HIF1α as a measure of tumor angiogenesis, after a single dose of bevacizumab as compared to placebo
Time frame: 4 years
•To estimate the rate of CHF in patients receiving TAC with or without bevacizumab
Time frame: 4 years
•To estimate the rates of left ventricular ejection fraction (LVEF) changes as measured by either a decrease of > 15% from baseline, or > 10% to a value below the lower limit of normal (for the institution), in patients receiving TAC or TAC + bevacizumab
Time frame: 4 years
•To investigate the clinical efficacy of TAC and TAC plus bevacizumab by estimating the clinical objective response rate (CR + PR), pathologic complete response rate (pCR), and rate of breast-conserving surgery (BCS)
Time frame: 4 years
•To estimate the rate of post-surgical wound healing complications in patients who receive surgery after TAC or TAC plus bevacizumab
Time frame: 4 years
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one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.
Marietta, Georgia, United States
South Texas Oncology and Hematology, P.A.
San Antonio, Texas, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
McGill University
Montreal, Quebec, Canada
St. Vincent's University Hospital
Dublin, Ireland
St. James's Hospital
Dublin, Ireland