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 objective of this study will be to determine the pathological response to neoadjuvant therapy using a combination of Letrozole and Bevacizumab in patients with pathologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast. Secondary objectives include evaluating 1) clinical response; 2) tolerability and toxicity; 3) specific biomarkers for prognostic value and as markers for response/resistance to the therapy; and 4) the correlation between 18 F-FDG PET scan 'metabolic response' with objective response rate and duration of response parameters. To be enrolled, patients must be 60 years or older, have measurable disease by mammogram and/or ultrasound, and ECOG performance status 0, 1 or 2. Prior to starting therapy, patients will have a PET scan. Blood counts, UA, 24-hour urine, urinary protein/creatinine ratio, and blood chemistries will be obtained. Mammogram and ultrasound of the breast will also be obtained and used as baseline evaluations. Patients will take oral Letrozole daily and receive Bevacizumab IV infusions every 3 weeks. At 6 weeks patients will have the first evaluation of response including mammogram/ultrasound of the breast and a PET scan. A biopsy will be performed for evaluation of biomarkers. Patients with objective response or stable disease will continue the same regimen with restaging every 6 weeks for a total of 18 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 #
7380478
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
$7,755
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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