BEVACIZUMAB AND DOCETAXEL FOR LOCALLY ADVANCED BREAST CANCER

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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 study investigates primary therapy with bevacizumab and docetaxel for locally advanced (Stage IIIa and IIIb) breast cancer. Both drugs target angiogenesis, and pre-clinical data support a beneficial anti-tumor effect, therefore the primary hypothesis of this protocol is that a greater percentage of patients receiving combination therapy are expected to have a pathologic disease response compared with those patients receiving docetaxel alone. The responding patients should exhibit a reduction in tumor microvascular density, increased tumor apoptosis, and decreased MRI-tumor perfusion. Patients with tumors exhibiting enhanced expression of nuclear clusterin/XIP8 should demonstrate enhanced clinical and pathologic response to bevacizumab and docetaxel administration. All patients will be randomized at entry to either docetaxel alone or docetaxel with bevacizumab. All patients will receive two 8-week cycles consisting of docetaxel weekly for six weeks with a two-week break. Those patients randomized to bevacizumab will also receive bevacizumab every 2 weeks without break. After two cycles, patients with stable or responsive disease will undergo definitive breast surgery. All patients will receive definitive radiation therapy following surgery. Further chemotherapy will follow radiation therapy. Patients with estrogen and/or progesterone receptor positive disease will receive five years of Tamoxifen 20 mg daily oral therapy following completion of post-radiation chemotherapy.