Preoperative Dose-dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab in Operable Breast Cancer

Inclusion Criteria:

Documented primary invasive breast cancer by histologic assessment
Tumors must express estrogen (ER) and/or progesterone receptors (PR) by standard immunohistochemical methods. Tumors must be negative for HER2. There must be sufficient sample for further protocol-specified immunohistochemical analysis
Patients must have high risk ER+ or PR+ breast cancer as defined by criteria listed in protocol
18 year of age or older
Performance status of 0 or 1 by ECOG criteria
Use of an effective means of contraception in subjects of childbearing potential
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to starting therapy.
Patients taking exogenous sex-steroid hormone treatments for any reason at the time of diagnosis must discontinue all hormonal treatments at least 2 weeks prior to enrollment
Patients must have preoperative treatment within 60 days of initial diagnosis of breast cancer
No other malignancy that requires on-going treatment
Normal organ function as outlined in the protocol

Exclusion Criteria:

Prior cytotoxic chemotherapy or radiation for the current breast cancer
Patients with inflammatory breast cancer
HER2 positive disease defined as HER2-amplified by FISH or IHC 3+. HER2 2+ must be negative by FISH
Known metastatic (Stage IV) disease
Other investigational agents within 4 weeks prior to the start of study treatment
Life expectancy of less than 6 months
Peripheral neuropathy greater than or equal to grade 2
Inadequately controlled hypertension
Any prior history of hypertensive crisis or hypertensive encephalopathy
NYHA grade II or greater congestive heart failure
History of prior myocardial infarction
History of unstable angina within 12 months prior to study enrollment
Any history of stroke or transient ischemic attack at any time
Known CNS disease
Significant vascular disease
Symptomatic peripheral vascular disease
Evidence of significant bleeding within 6 months of study; any serious non-healing wound, skin ulcers, or bone fracture; any abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the past 6 months; any major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during course of study.
Known HIV positive
Unwilling to undergo pretreatment biopsy and consent to acquisition of archival tissue
Pregnant of lactating
Known hypersensitivity to any component of bevacizumab