Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed invasive breast cancer
• * Metastatic disease
• HER2/neu-positive by immunohistochemistry (3+ by HercepTest\^™ or equivalent) OR positive for amplification by fluorescent in situ hybridization
• * Testing may be performed in the primary tumor or the metastatic site
• Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease
• Measurable disease
• * At least one measurable lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan
• * The following are considered non-measurable disease:
• * Bone lesions
• * Leptomeningeal disease
• * Ascites
• * Pleural/pericardial effusion
• * Inflammatory breast disease
• * Lymphangitis cutis/pulmonis
• * Abdominal masses that are not confirmed and followed by imaging techniques
• * Cystic lesions
• No bone metastases as the only evidence of metastasis
• Previously treated CNS metastases allowed provided disease has been stable for ≥ the past 3 months
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female or male
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm\^3
• No known uncontrolled coagulopathy
• Hepatic
• Bilirubin ≤ 3.0 times the upper limit of normal (ULN)
• One of the following must be true:
• * AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
• * Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal
• * Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
• INR ≤ 1.5 times ULN
• Renal
• Calcium ≤ 11.5 mg/dL
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance ≥ 30 mL/min
• Cardiovascular
• LVEF ≥ 50% by MUGA or echocardiogram
• No clinically significant (i.e., active) cardiac disease
• No congestive heart failure
• No symptomatic coronary artery disease
• No myocardial infarction within the past 12 months
• No cardiac arrhythmia not controlled with medication
• Gastrointestinal
• Able to take oral medication
• No lack of physical integrity of the upper gastrointestinal tract
• No clinically significant malabsorption syndrome
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after study participation
• No history of allergy or hypersensitivity to study drugs, drug product excipients, including polysorbate 80, or chemically similar agents
• No prior unanticipated severe reaction to fluoropyrimidine therapy
• No know hypersensitivity to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No history of uncontrolled seizures or CNS disorders
• No clinically significant psychiatric disability that would preclude giving informed consent or study compliance
• No other serious uncontrolled infection or disease
• No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Prior adjuvant trastuzumab (Herceptin\^®) allowed as adjuvant or first-line therapy for metastatic disease
• No concurrent immunotherapy
• Chemotherapy
• See Disease Characteristics
• No more than 1 prior chemotherapy regimen in the advanced or metastatic (non-adjuvant) setting
• No prior continuous (≥ 24 hours) fluorouracil infusion
• No prior capecitabine
• No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and tegafur, S1, or emitefur)
• Endocrine therapy
• At least 1 day since prior hormonal therapy
• No concurrent hormonal therapy
• Radiotherapy
• More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal column, sternum, or ribs)
• No concurrent radiotherapy
• Surgery
• More than 4 weeks since prior major surgery
• No prior organ allografts requiring immunosuppressive therapy
• Other
• More than 4 weeks since prior investigational drugs
• No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
• No concurrent allopurinol, metronidazole, or cimetidine
• No other concurrent cytotoxic agents
• No other concurrent investigational drugs
• No other concurrent anticancer therapy