Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer

You may be eligible if

• Histologically or cytologically confirmed stage IV breast cancer
• * Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study
• Must meet 1 of the following criteria:
• * Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease
• * Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease
• At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria:
• * At least 20 mm by conventional techniques
• * At least 10 mm by spiral CT scan
• No CNS metastases by CT scan or MRI within the past 6 weeks
• No prior or concurrent primary CNS tumor on physical exam
• Disease progression after bone marrow or peripheral blood stem cell transplantation allowed
• HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin)
• Hormone receptor status:
• * Not specified
• Male or female
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• Absolute neutrophil count at least 1,500/mm\^3
• Hemoglobin at least 9 g/dL
• Platelet count at least 100,000/mm\^3
• No prior bleeding diathesis or coagulopathy
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN
• INR no greater than 1.5
• Creatinine less than 2 mg/dL
• Urine protein no greater than +1 by dipstick
• Urine protein less than 500 mg by 24-hour urine collection
• LVEF at least 50%
• No prior stroke
• No New York Heart Association class II-IV congestive heart failure
• No serious cardiac arrhythmia requiring medication, including atrial fibrillation requiring systemic anticoagulation
• No grade II or greater peripheral vascular disease within the past year
• No clinically significant peripheral artery disease
• No deep vein thrombosis or embolism within the past 5 years
• No arterial thromboembolic event within the past 6 months, including any of the following:
• * Transient ischemic attack
• * Cerebrovascular accident
• * Unstable angina
• * Myocardial infarction
• No other significant cardiovascular disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No evidence of seizures not controlled with standard medical therapy
• No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study
• Prior mild infusion reaction to trastuzumab allowed
• No serious non-healing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 4 weeks
• No other concurrent illness (such as active infection) that would require active treatment or preclude study
• No psychiatric illness or social situation that would preclude study
• See Disease Characteristics
• No prior bevacizumab
• No other prior experimental angiogenesis inhibitors
• At least 2 weeks since prior trastuzumab and recovered
• Concurrent epoetin alfa or filgrastim (G-CSF) allowed
• See Disease Characteristics
• At least 2 weeks since prior chemotherapy and recovered
• No prior vinorelbine
• No more than 2 prior conventional chemotherapy regimens for metastatic breast cancer
• Prior hormonal therapy allowed
• At least 1 week since prior radiotherapy and recovered
• No concurrent radiotherapy
• At least 4 weeks since prior major surgical procedure or open biopsy
• At least 1 week since prior fine-needle aspiration except in the breast
• No concurrent major surgical procedure
• Recovered from the toxic effects of any prior therapy
• At least 10 days since prior oral or parenteral anticoagulants (e.g., heparin or warfarin) except to maintain the patency of permanent, indwelling central venous catheter
• At least 10 days since prior thrombolytic agents
• No chronic aspirin therapy greater than 325 mg per day or non-steroidal anti-inflammatory medications that inhibit platelet function
• No concurrent COX-2 inhibitors that inhibit platelet function
• No other concurrent investigational or commercial agents or therapies for the malignancy
• No concurrent antiretroviral therapy for HIV-positive patients
• No concurrent ketoconazole, zidovudine, or macrolide antibiotics
• No concurrent oral or parenteral anticoagulants except to maintain patency of permanent, indwelling central venous catheter
• No concurrent thrombolytic agent
• Concurrent bisphosphonates allowed
• Concurrent celecoxib or rofecoxib allowed