Bevacizumab, Docetaxel, and Carboplatin in Treating Women With Stage II or Stage III Breast Cancer

OBJECTIVES:

• To determine the rate of pathological complete response in women with operable triple-negative breast cancer treated with neoadjuvant bevacizumab, docetaxel, and carboplatin.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV, docetaxel IV, and carboplatin IV on day 1. Treatment repeat every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients receive docetaxel IV and carboplatin IV only during course 6. Patients undergo surgery between weeks 19-21 as planned.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Stage II or III disease
• No evidence of metastasis (M0)
• No inflammatory breast cancer (T4d)
• Must have a primary tumor
• Operable disease
• Triple-negative disease, meeting the following criteria:

• Estrogen receptor-, progesterone receptor-, and HER2-negative by immunohistochemistry (IHC) 0 or 1+ OR fluorescence in situ hybridization negative (in case IHC is 2+)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Pre- or post-menopausal
• Not pregnant
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥10 g/dL
• Serum creatinine ≤ 1.5 mg/dL
• Total bilirubin ≤ 1.5 mg/dL
• AST/ALT ≤ 2 times normal
• Alkaline phosphatase ≤ 2 times normal
• Normal or nonspecific EKG
• LVEF ≥ 50% by MUGA or echocardiogram
• Normal mental function to understand and sign the written informed consent
• No history of uncompensated congestive heart failure
• No history of cancer except for carcinoma in situ of the uterine cervix or nonmelanoma skin cancer
• No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
• No uncontrolled hypertension (systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg)
• No history or evidence of clinically significant cardiovascular disease, including any of the following:

• Cerebrovascular accident (CVA) or stroke within the past 6 months
• Myocardial infarction (MI) within the past 6 months
• Unstable angina
• NYHA class II-IV congestive heart failure
• Serious cardiac arrhythmia requiring medication
• No serious nonhealing wound, peptic ulcer, or bone fracture
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No known hypersensitivity to any of the study drugs

PRIOR CONCURRENT THERAPY:

• No prior hormone therapy, chemotherapy, or radiotherapy for breast cancer
• No prior breast surgery other than biopsy to confirm diagnosis
• No concurrent chronic daily corticosteroids (more than 10 mg/day methylprednisolone equivalent)