Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• * Metastatic or locally advanced unresectable disease
• At least 1 measurable target lesion that has not been irradiated
• * New lesions in a previously irradiated field allowed as sites of measurable disease
• Progressive disease after more than 2 months of aromatase inhibitor therapy
• No known CNS disease or unevaluated CNS symptoms suggestive of brain metastases
• Hormone receptor status:
• * Estrogen receptor or progesterone receptor positive
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Post-menopausal by 1 of the following criteria:
• * Age 50 and over and has not menstruated during the past year or has castrate follicle-stimulating hormone (FSH) levels (greater than 40 IU/L)
• * Under age 50 and has castrate FSH levels
• * Received prior bilateral oophorectomy and has castrate FSH levels
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
• Renal
• Creatinine no greater than 1.5 times ULN
• Cardiovascular
• No history of congestive heart failure requiring therapy
• No ventricular arrhythmia requiring therapy
• No unstable angina pectoris
• No myocardial infarction within the past 6 months
• Other
• Able to swallow oral medication
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No known malabsorption condition or other condition that would impair absorption of study drug
• No active infection
• No other concurrent medical condition that would preclude study
• No known severe hypersensitivity to ZD 1839 or any excipients
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• No prior chemotherapy except in adjuvant setting
• No concurrent chemotherapy for breast cancer
• Endocrine therapy
• See Disease Characteristics
• More than 30 days since other prior hormonal therapy (including hormone replacement therapy and megestrol)
• Concurrent steroids for other reasons besides skin toxicity allowed
• No other concurrent hormonal therapy (including megestrol) for breast cancer
• Radiotherapy
• See Disease Characteristics
• Surgery
• Recovered from prior oncologic or other major surgery
• No concurrent ophthalmic surgery
• Other
• More than 30 days since prior anticancer therapy
• More than 30 days since prior non-approved or investigational drugs
• No prior epidermal growth factor receptor or HER2 blockers
• No concurrent phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, Hypericum perforatum, or systemic retinoids
• No other concurrent investigational therapy for breast cancer
• Concurrent bisphosphonates for metastatic bone disease allowed