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

This is an interventional treatment trial for Breast Cancer focused on measuring cardiac toxicity, perioperative/postoperative complications, HER2-negative breast cancer, male breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer Read More

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