Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed invasive breast cancer
• •HER2-negative disease
• •* IHC 0/1 OR IHC 2+ and FISH negative
• •Must meet 1 of the following criteria:
• •* Unifocal tumor meeting 1 of the following criteria:
• •* T2 or T3 tumors (radiological size \> 20 mm)
• •* T4 tumor of any size with direct extension to the chest wall or the skin
• •* Inflammatory carcinoma with tumor of any size
• •* Multifocal tumor meeting the following criteria:
• •* The sum of each tumors' maximum diameter must be ≥ 20 mm (total radiological tumor size ≥ 20 mm)
• •* Other locally advanced disease meeting 1 of the following criteria:
• •* Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter \> 20 mm or clinical N2) and primary breast tumor of any diameter
• •* Any T stage with involvement of large or fixed axillary lymph nodes (radiological diameter \> 20 mm or clinical N2), without a primary breast tumor identified and the presence of breast cancer in a lymph node must be histopathologically confirmed by lymph node biopsy (tru-cut or whole lymph node)
• •Embedded paraffin tumor block available from pre-chemotherapy biopsy and surgical specimen
• •Bilateral disease allowed
• •No evidence of metastatic disease
• •No prior breast cancer except for ductal carcinoma in situ of the breast surgically cured \> 10 years ago
• •Any hormone receptor status
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •WBC \> 3 x 10\^9/L
• •Hemoglobin \> 10 g/dL
• •Platelet count \> 100 x 10\^9/L
• •AST/ALT ≤ 1.5 times upper limit of normal (ULN)
• •Alkaline phosphatase ≤ 2 times ULN
• •Bilirubin normal
• •* Isolated elevation of bilirubin to ≤ 3 times ULN with a presumptive diagnosis of Gilbert syndrome allowed if AST/ALT and alkaline phosphatase are within normal limits
• •Creatinine ≤ 1.5 times ULN
• •PT and PTT/aPTT ≤ 1.5 times ULN
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception
• •Must be fit to receive chemotherapy on this trial, in the opinion of the responsible clinician, as indicated by the following criteria:
• •* No clinically significant cardiac abnormalities
• •* No myocardial infarction within the past 6 months
• •* LVEF normal (at least 50%) by MUGA scan or echocardiogram
• •No prior ischemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, inflammatory bowel disease, gastroduodenal ulcer, symptomatic diverticulitis, or bleeding diathesis
• •No uncontrolled hypertension (systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg) with or without antihypertensive medication
• •* Patients with initial blood pressure elevations are eligible provided initiation or adjustment of antihypertensive medication lowers pressure to meet entry criteria
• •No other previous malignancy except basal cell carcinoma, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast treated by surgery only and disease-free for 10 years
• •No concurrent medical or psychiatric problem that might prevent completion of treatment or follow-up
• •No presence of active uncontrolled infection
• •No history of nephritic or nephrotic syndrome
• •No traumatic injury within the past 28 days
• •No evidence of other disease that, in the opinion of the investigator, places the patient at high risk of treatment-related complications
• •No nonhealing wound, peptic ulcer, or bone fracture
• •PRIOR CONCURRENT THERAPY:
• •No prior neoadjuvant endocrine therapy
• •No prior chemotherapy or radiotherapy
• •No major surgical procedure within the past 28 days
• •No concurrent full therapeutic dose of anticoagulants or aspirin \> 325 mg/day, clopidogrel \> 75 mg/day, or corticosteroids