This purpose of this trial is to show that the combination of Avastin and hormone therapy should be more effective than hormone therapy alone for the treatment of breast cancer.
Preclinical and clinical data have demonstrated that up-regulation of tumor cell VEGF is an important mechanism to subvert estrogen dependence in hormone responsive breast cancer resulting in reduced therapy response or tumor resistance to hormonal therapy; thus, it is hypothesized that the combination of an anti-VEGF agent (Avastin, an anti-VEGF monoclonal antibody) and hormonal therapy should be more effective than hormonal therapy alone for the treatment of breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Letrozole 2.5 mg PO a day for 24 weeks
Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, San Francisco Comprehensive Cancer Center
San Francisco, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Georgia Cancer Specialists
The Percentage of Participants With Pathologic Complete Response
Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.
Time frame: 24 weeks
Letrozole +Avastin
Radiographic objective response to the therapy are reported. Radiographic response was assessed using RECIST criteria by ultrasound or breast MRI through the study and are reported as complete radiographic response below.
Time frame: 24 weeks
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Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States