This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objectives of this study will be to determine if acquired hormone therapy resistance can be reversed by Bevacizumab, as measured by time to progression and to evaluate toxicity of the combination of hormone treatment plus Bevacizumab. Secondary objectives include determining response rate and correlating 18F-FDG PET scan 'metabolic response' with objective response rate and duration of response parameters. It is hypothesized that up-regulation of tumor cell VEGF is an important mechanism to subvert estrogen dependence in hormone responsive breast cancer patients resulting in tumor progression in patients previously responding to hormonal therapy, and the addition of an anti-VEGF antibody, Bevacizumab, to the hormonal therapy will reverse this acquired resistance. To be enrolled, patients must have evaluable disease, must have responded to first or second line hormonal therapy and became resistant to the hormonal agent, and ECOG performance status 0, 1 or 2. Prior to starting therapy, patients will have a PET scan, evaluation of heart function (echocardiogram), standard disease assessments (CT scans, MRI, etc.), and appropriate laboratory evaluations. Patients will take the same oral hormonal therapy they had taken previously and in addition, will receive Bevacizumab IV infusions every 3 weeks. At 6 weeks patients will have the first evaluation of response including a PET scan. Patients with objective response or stable disease will continue the same regimen with restaging every 6 weeks or until progression is observed.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000032-46
Application #
7380479
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-03-01
Project End
2007-02-28
Budget Start
2006-03-01
Budget End
2007-02-28
Support Year
46
Fiscal Year
2006
Total Cost
$3,525
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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