Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast
• * Metastatic disease
• HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization)
• Measurable or evaluable disease
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Male or female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• AST and ALT \< 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastases)
• Bilirubin \< 1.5 times ULN
• No unstable or uncompensated hepatic disease
• Renal
• Creatinine \< 1.6 mg/dL
• No unstable or uncompensated renal disease
• Cardiovascular
• LVEF \> 45% by echocardiogram or MUGA
• No prior New York Heart Association class I-IV heart disease
• No prolonged PR interval or atrioventricular block on ECG
• No unstable or uncompensated cardiac disease
• Pulmonary
• No unstable or uncompensated respiratory disease
• No clinically active interstitial lung disease
• * Patients who are asymptomatic and have chronic stable radiographic changes are allowed
• Immunologic
• No autoimmune disorders
• No conditions of immunosuppression
• No severe hypersensitivity to taxane or gefitinib or any of its excipients
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other prior or concurrent malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
• No other severe or uncontrolled systemic disease
• No other acute or chronic medical condition that would preclude study participation
• No other significant clinical disorder or laboratory finding that would preclude study participation
• No psychiatric illness that would preclude study compliance
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Prior adjuvant trastuzumab (Herceptin®) allowed if \> 6 months elapsed before disease recurrence
• No prior trastuzumab for metastatic breast cancer
• No prior monoclonal antibodies directed at the epidermal growth factor receptor (EGFR)
• Chemotherapy
• Prior adjuvant chemotherapy (or as first-line therapy for metastatic breast cancer) allowed
• Prior adjuvant taxane allowed if completed \> 6 months before diagnosis of metastatic breast cancer
• No prior docetaxel for metastatic breast cancer
• Endocrine therapy
• Prior adjuvant hormonal therapy (or as first-line therapy for metastatic breast cancer) allowed
• No concurrent hormonal therapy
• * Concurrent steroids allowed provided dose is stable
• Radiotherapy
• Not specified
• Surgery
• Fully recovered from prior oncologic or other major surgery
• No concurrent surgery within 7 days of gefitinib administration
• Other
• Recovered from prior anticancer therapy (alopecia allowed)
• More than 30 days since prior non-approved drug or investigational agent
• No other prior EGFR-directed therapy (i.e., tyrosine kinase inhibitors)
• No concurrent use of any of the following medications:
• * Phenytoin
• * Carbamazepine
• * Barbiturates
• * Rifampin
• * Hypericum perforatum (St. John's wort)
• No other concurrent anticancer therapy
• No concurrent cardioprotective drugs
• No concurrent oral retinoids
• Concurrent participation in the City of Hope indium-labeled trastuzumab imaging study allowed