S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or pathologically confirmed breast cancer meeting one of the following criteria:
• Locally advanced disease (stage IIIB disease, stage IIB/IIIA, or stage IIIC disease)
• Inflammatory disease meeting the following two clinicopathologic criteria:
• Diffuse erythema AND edema (peau d'orange) of the breast involving the majority of the skin of the breast, i.e., more than 50%
• A biopsy demonstrating cancer either within the dermal lymphatics OR in the breast parenchyma itself
• HER2/neu-negative tumor as demonstrated by 0 or 1+ (weak or no staining) by DAKO, IHC, or equivalent test OR no gene amplification by FISH*
• 2+ by DAKO or IHC allowed provided FISH* negative
• NOTE: *A negative FISH test ratio is 1,500/mm^3
• ANC ≥ 1,500/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin 9.0 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 mg/dL
• ALT and AST ≤ 3 times ULN
• Alkaline phosphatase ≤ 2.5 ULN (unless bone metastasis is present in the absence of liver metastasis)
• Urine protein: creatinine ratio ≤ 0.5 OR urine protein 60 years of age)
• NYHA class II cardiac function by baseline ECHO/MUGA (for patients who have received central thoracic radiotherapy that included the heart in the radiotherapy port, or for patients who have a history of class II heart failure but are asymptomatic on treatment are eligible)
• No history of stroke (cerebrovascular accident), transient ischemic attack, or cardiac event within the past 12 months, including any of the following:
• Myocardial infarction (including severe/unstable angina)
• Coronary/peripheral artery bypass graft
• Symptomatic congestive heart failure
• Pulmonary embolism
• No poorly controlled hypertension, defined as recurrent or persistent (≥ 24 hours) elevated blood pressure (i.e., systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg)
• No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• Peripheral neuropathy < grade 2

PRIOR CONCURRENT THERAPY:

• No prior tyrosine kinase inhibitors
• More than 5 years since prior chemotherapy, radiotherapy, or biologic therapy (e.g., trastuzumab or bevacizumab) for invasive breast cancer
• At least 7 days since prior hormonal therapy
• At least 7 days since prior and no concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or grapefruit juice
• No concurrent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's wort)
• No other concurrent therapy for the treatment of breast cancer except for bisphosphonates
• No concurrent brachytherapy