Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer

Inclusion Criteria

• •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