This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This randomized phase II study has an accrual goal of 200 participants and we anticipate 15 to 30 here at UAB.It is unknown how to best use Bevacizumab in combination with chemotherapy for patients with newly diagnosed breast cancer. The purpose of this study is to examine whether the use of bevacizumab along with chemotherapy drugs commonly used in treating newly diagnosed patients with breast cancer (in this study doxorubicin and cytoxan) is safe. Specifically, this study will determine if adding bevacizumab increases the effect of chemotherapy on heart function.Eligible consents participants will be randomized to one of the following arms:Group A - Participants will receive Adriamycin , Cytoxan (AC) and bevacizumab (an investigational agent that inhibits the formation of blood vessels) by vein over about one hour one day every two weeks for a total of 4 treatments. After all treatment with AC plus bevacizumab is done, participants will receive Taxol and bevacizumb by vein over about 3-4 hours every two weeks for 4 treatments. After all treatment with Taxol plus bevacizumab is done, participants will receive bevacizumab by vein over about 30 minutes one day every two weeks for a total of 18 treatments. The first dose of bevacizumab will be given over about 90 minutes.Group B - Participants will receive Adriamycin , Cytoxan (AC) by vein over about 30 minutes one day every two weeks for a total of 4 treatments. After all treatment with AC is done, a participant will receive Taxol and bevacizumab (an investigational agent that inhibits the formation of blood vessels) by vein over about 3-4 hours every two weeks for 4 treatments. After all treatment with Taxol plus bevacizumab is done, a participant will receive bevacizumab by vein over about 30 minutes one day 1 every two weeks for a total of 22 treatments. The first dose of bevacizumab will be given over about 90 minutes. If a participant does well with the first dose, the second dose will be given over one hour. If a participant does well with the second dose, other doses of bevacizumab will be given over about 30 minutes.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000032-47
Application #
7603255
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-03-01
Project End
2008-02-29
Budget Start
2007-03-01
Budget End
2008-02-29
Support Year
47
Fiscal Year
2007
Total Cost
$12,732
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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