ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive breast cancer
• Recurrent or metastatic disease OR locally recurrent disease not amenable to resection with curative intent
• Measurable or nonmeasurable disease
• No CNS metastases by CT scan or MRI
• No HER2-neu-positive tumors
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• Performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count > 100,000/mm³
• Creatinine < 2.0 mg/dL
• Bilirubin normal
• AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if there is known liver involvement)
• Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1 g protein on 24-hour urine collection
• No peripheral neuropathy > grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancies within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin
• No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications
• No prior hypertensive crisis or hypertensive encephalopathy
• No New York Heart Association class II-IV congestive heart failure
• No myocardial infarction or unstable angina within the past 6 months
• No stroke or transient ischemic attack within the past 6 months
• No significant vascular disease (e.g., aortic aneurysm or aortic dissection)
• No symptomatic peripheral vascular disease
• No evidence of bleeding diathesis or coagulopathy
• No significant traumatic injury within the past 28 days
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No serious, nonhealing wound, ulcer, or bone fracture
• No known hypersensitivity to any component of bevacizumab

PRIOR CONCURRENT THERAPY:

• No prior paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane^®) or bevacizumab
• No prior chemotherapy for metastatic disease
• Prior hormonal therapy for metastatic disease allowed
• At least 4 weeks since any prior therapy for cancer
• More than 12 months since prior adjuvant chemotherapy, including use of a taxane
• More than 28 days since prior major surgery or open biopsy
• More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device)
• No concurrent major surgery
• No other concurrent therapy for breast cancer
• Concurrent bisphosphonates allowed if there is bone involvement
• No concurrent prophylactic granulocyte colony-stimulating factors