Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive breast cancer
• Clinical evidence of metastatic disease
• No bone metastases as the only evidence of metastasis
• Measurable disease
• At least 1 lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan
• Lesions on chest x-ray allowed provided they are clearly defined and surrounded by aerated lung
• Clincal lesions only considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)
• Target lesion must not have been exposed to prior radiotherapy unless disease has progressed since completion of radiotherapy
• The following are not considered measurable disease:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural or pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis or pulmonis
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• No HER2/neu-positive tumors by immunohistochemistry or amplified fluorescence in situ hybridization unless disease has progressed after trastuzumab (Herceptin®)-containing therapy alone or with antiestrogen hormonal therapy for metastatic disease OR trastuzumab is contraindicated
• Prior breast cancer allowed
• No prior or active brain metastases
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8.0 g/dL
• No bleeding diathesis or uncontrolled coagulopathy

Hepatic

• Bilirubin normal
• Meets 1 of the following criteria:
• AST and ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
• AST and ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
• AST and ALT ≤ 5 times ULN AND alkaline phosphatase normal

Renal

• Creatinine clearance ≥ 30 mL/min
• No proteinuria OR
• Protein < 1 g by 24-hour urine collection
• No nephrotic syndrome

Cardiovascular

• No uncontrolled hypertension (i.e., blood pressure > 160/90 mm Hg on ≥ 2 different observations ≥ 5 minutes apart)
• Blood pressure < 140/90 mm Hg on ≥ 3 different observations over ≥ 14 days, for patients who recently began or adjusted anti-hypertensive medication
• No atrial or venous thrombosis within the past month
• No clinically significant heart disease, including any of the following:
• Congestive heart failure
• Symptomatic coronary artery disease
• Uncontrolled cardiac arrhythmias
• Unstable angina
• No myocardial infarction within the past 12 months
• No history of cerebrovascular accident

Pulmonary

• No hemoptysis within the past 6 months

Gastrointestinal

• No lack of physical integrity of the upper gastrointestinal tract
• No malabsorption syndrome
• Able to receive oral medication

Other

• No other stage III or IV invasive malignancy requiring treatment within the past 5 years
• No pre-existing peripheral neuropathy > grade 1
• No history of allergy or hypersensitivity to study drugs, agents that are chemically similar to study drugs, or drugs that contain polysorbate 80
• No prior severe reaction to fluoropyrimidines
• No known hypersensitivity to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No active infection
• No significant medical condition that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• No other concurrent biologic therapy

Chemotherapy

• Prior adjuvant or neoadjuvant chemotherapy allowed for primary disease
• No prior chemotherapy for metastatic disease
• More than 4 weeks since prior cytotoxic chemotherapy
• More than 6 months since prior taxanes (e.g., docetaxel or paclitaxel)
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• Prior antiestrogen hormonal therapy allowed in the adjuvant or metastatic setting

Radiotherapy

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy to a target lesion
• Prior single-dose palliative radiotherapy allowed within the past 4 weeks
• No concurrent radiotherapy

Surgery

• More than 4 weeks since prior major surgery

Other

• More than 2 weeks since prior aspirin, anticoagulants, or thrombolytic agents
• Concurrent low-dose warfarin (1 mg/day) to maintain patency of vascular access device allowed
• More than 4 weeks since prior investigational agents
• No concurrent aspirin, anticoagulants, or thrombolytic agents
• No concurrent participation in another clinical trial involving investigational agents or procedures