E2104 TRIAL OF AVASTIN DD ADRIAMYCIN AND CYTOXAN FOLLOWED BY TAXOL IN LYMPH NODE

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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. 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.