Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer

Date de début de l'étude : 1 décembre 2004

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