Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria: Histologically confirmed metastatic adenocarcinoma of the breast Patients may have had or not had standard first-line chemotherapy for the treatment of metastatic disease Overexpression of HER2-neu (HER2 3+ by immunohistochemistry or gene amplification as measured by fluorescent in situ hybridization) Measurable disease Patients with no prior adjuvant chemotherapy may have failed or not failed first-line chemotherapy for metastatic disease No more than 2 prior systemic chemotherapy regimens for metastatic disease Relapse while receiving or within 6 months of completion of adjuvant chemotherapy is considered failure of 1 regimen for metastatic disease No untreated brain metastases or brain metastases undergoing radiotherapy Previously treated brain metastasis that has responded to radiotherapy and/or surgery allowed if not sole site of measurable disease Hormone receptor status: Not specified Male or female Performance status - ECOG 0-2 Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases is present) INR no greater than 1.5 times ULN PT and PTT no greater than 1.5 times ULN Creatinine no greater than 1.5 mg/dL No more than trace blood or protein in urine LVEF ≥ 50% by MUGA scan No prior New York Heart Association class I-IV heart disease No PR prolongation or atrioventricular block on ECG Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception (preferably nonhormonal) Random blood sugar less than 2.5 times ULN No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation No prior trastuzumab (Herceptin) No other concurrent immunologic therapy See Disease Characteristics Recovered from prior cytotoxic chemotherapy No prior cumulative dose of doxorubicin more than 360 mg/m^2 No concurrent chemotherapy At least 2 weeks since prior hormonal therapy No concurrent hormonal therapy, including tamoxifen No concurrent dexamethasone, progesterone, or glucocorticoids See Disease Characteristics At least 2 weeks since prior radiotherapy No prior radiotherapy to target lesions or only site of measurable disease No concurrent radiotherapy See Disease Characteristics No prior organ allograft No prior gefitinib No prior immunosuppressive therapy At least 2 weeks since prior cytotoxic drugs No concurrent carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, Hypericum perforatum (St. John's Wort), sulfadimidine, sulfinpyrazone, troglitazone, or grapefruit juice No other concurrent investigational agents No concurrent topical eye agents Concurrent bisphosphonates allowed for hypercalcemia and/or prophylaxis of bone metastases