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

Inclusion Criteria

• •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