Phase II Bevacizumab + Tax In Advanced Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast
• * Stage IIIA or IIIB
• * Stage IV if patient has clinical evidence of locally advanced breast cancer only
• * Inoperable disease
• Prior carcinoma in situ of the breast or bilateral breast cancer is allowed
• No CNS metastases
• Hormone receptor status:
• * Estrogen and progesterone receptor status known
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Sex:
• Female or male
• Menopausal status:
• Not specified
• Performance status:
• ECOG 0-2 OR
• Karnofsky 60-100%
• Life expectancy:
• More than 6 months
• Hematopoietic:
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin normal (no greater than 2 times upper limit of normal \[ULN\] in patients with an inherited disorder)
• AST/ALT no greater than 2.5 times ULN
• INR and PTT normal
• Renal:
• Creatinine normal OR
• Creatinine clearance at least 60 mL/min
• No proteinuria or clinically significant renal impairment
• Cardiovascular:
• LVEF at least 45% by echocardiogram or MUGA scan
• No New York Heart Association class III or IV heart disease
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No inadequately controlled hypertension
• No history of deep vein thrombosis or other thromboses
• No clinically significant peripheral artery disease
• No arterial thromboembolic event within the past 6 months including the following:
• * Transient ischemic attack
• * Cerebrovascular accident
• * Myocardial infarction
• Other:
• No other prior or concurrent malignancy within the past 10 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other uncontrolled concurrent illness
• No ongoing or active infection
• No non-healing wounds
• No psychiatric illness or social situation that would preclude study participation
• No prior allergic reaction to compounds of similar chemical or biological composition to bevacizumab, docetaxel, polysorbate 80 (Tween) formulations, or other agents used in this study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No concurrent cytokines during docetaxel/bevacizumab administration
• * Concurrent cytokines during doxorubicin/cyclophosphamide administration allowed at the discretion of the treating physician
• Chemotherapy:
• No prior chemotherapy
• Endocrine therapy:
• Prior hormonal therapy (e.g., tamoxifen) allowed
• Radiotherapy:
• Prior radiotherapy to affected breast allowed
• Surgery:
• More than 28 days since prior major surgery
• Other:
• At least 10 days since prior thrombolytic agents
• At least 10 days since prior full-dose oral or parenteral anticoagulants except to maintain patency of permanent indwelling IV catheters
• Concurrent warfarin allowed provided INR is less than 1.5
• Concurrent bisphosphonates allowed for osseous metastases provided they are not initiated on day 1 of cycle 1
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent full-dose oral or parenteral anticoagulants except to maintain patency of permanent indwelling IV catheters
• No concurrent thrombolytic agents
• No other concurrent anticancer agents or therapies
• No other concurrent investigational agents