Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer

Exclusion Criteria

• •Refractory disease, defined as disease progression, drug-related adverse reaction, or disease relapse during or within 12 months after completion of paclitaxel or docetaxel AND doxorubicin or epirubicin administered in the neoadjuvant, adjuvant, or metastatic setting
• •* Total neoadjuvant or adjuvant taxane dose \> 700 mg/m\^2 for paclitaxel or \> 240 mg/m\^2 for docetaxel
• •* Total taxane dose \> 350 mg/m\^2 for paclitaxel or \> 120 mg/m\^2 for docetaxel in the metastatic setting
• •* Total neoadjuvant or adjuvant anthracycline dose \> 240 mg/m\^2 for doxorubicin or epirubicin
• •* Total anthracycline dose \> 120 mg/m\^2 for doxorubicin or epirubicin in the metastatic setting
• •HER2/neu overexpression
• •* 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
• •No symptomatic brain metastases
• •No pleural or pericardial effusion or ascites
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age
• •20 to 75
• •Sex
• •Female
• •Menopausal status
• •Not specified
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •At least 3 months
• •Hematopoietic
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9.0 g/dL
• •Hepatic
• •SGOT or SGPT ≤ 2.0 times upper limit of normal (ULN) (\< 3.0 times ULN for patients with liver metastases)
• •Alkaline phosphatase ≤ 2.5 times ULN
• •Bilirubin ≤ 1.5 mg/dL
• •Renal
• •Creatinine ≤ 1.2 mg/dL
• •Cardiovascular
• •LVEF \> 50%
• •Pulmonary
• •No interstitial pneumonia with pulmonary fibrosis
• •Other
• •No history of hypersensitivity reactions
• •No serious, uncontrolled infection
• •No other malignancy
• •Not pregnant or nursing
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Prior trastuzumab (Herceptin®) for metastatic disease allowed
• •Chemotherapy
• •See Disease Characteristics
• •No prior capecitabine
• •At least 2 weeks since prior antimetabolites for metastatic disease
• •At least 4 weeks since prior alkylating agents, carcinostatic antibiotics, or other carcinostatic agents
• •Endocrine therapy
• •At least 4 weeks since prior goserelin or leuprolide for metastatic disease
• •At least 2 weeks since prior oral endocrine agents for metastatic disease
• •No concurrent endocrine therapy
• •Radiotherapy
• •No prior radiotherapy to target lesions
• •At least 4 weeks since prior radiotherapy
• •No concurrent radiotherapy, including radiotherapy for brain metastases
• •Surgery
• •Not specified
• •Other
• •Concurrent bisphosphonates for bone metastases allowed