Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS
• * No invasive disease
• * Not completely excised
• Epidermal growth factor receptor (EGFR) positive (\> 10% of cells stained)
• Planned lumpectomy or mastectomy within the next 2-4 weeks
• Hormone receptor status:
• * Estrogen receptor status known
• PATIENT CHARACTERISTICS:
• Age
• 35 and over
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• ECOG 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Granulocyte count \> 1,500/mm\^3
• Platelet count \> 100,000/mm\^3
• Hepatic
• Bilirubin \< 1.5 mg/dL
• SGOT ≤ 2 times upper limit of normal (ULN)
• SGPT \< 1.5 times ULN
• PT and PTT ≤ 1.5 times ULN
• INR ≤ 1.5 times ULN
• Renal
• Creatinine \< 1.5 mg/dL
• Cardiovascular
• No New York Heart Association class I-IV heart disease
• Pulmonary
• No acute asthma
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Random blood sugar \< 2.5 times ULN
• No known hypersensitivity to study drug or its excipients
• No nonhealing wound or fracture
• No active infection
• No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix
• No psychosis or severe depression
• No other concurrent uncontrolled illness
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior trastuzumab (Herceptin®)
• Chemotherapy
• At least 1 year since prior chemotherapy
• No concurrent chemotherapy
• Endocrine therapy
• At least 1 year since prior aromatase inhibitors
• At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists
• No concurrent glucocorticoids
• Concurrent oral contraceptives allowed
• Concurrent hormone replacement therapy allowed
• Radiotherapy
• At least 1 year since prior radiotherapy
• No concurrent radiotherapy
• Surgery
• See Disease Characteristics
• Recovered from prior oncologic or other major surgery
• No prior organ allograft
• Other
• Recovered from all prior therapy (except alopecia)
• More than 30 days since prior non-approved or investigational drugs
• No prior definitive local therapy
• No prior immunosuppressive therapy
• No prior gefitinib
• No other prior EGFR inhibitors
• No other concurrent cytotoxic drugs
• No concurrent warfarin for anticoagulation
• No concurrent CYP3A4 inducers, including any of the following:
• * Phenytoin
• * Carbamazepine
• * Barbiturates
• * Rifampin
• * Phenobarbital
• * Hypericum perforatum (St. John's wort)
• * Ethosuximide
• * Griseofulvin
• * Nafcillin
• * Nelfinavir
• * Nevirapine
• * Oxcarbazepine
• * Phenylbutazone
• * Primidone
• * Rifabutin
• * Rofecoxib
• * Sulfamethazine
• * Sulfinpyrazone
• * Troglitazone
• No concurrent antiretroviral treatment for HIV-positive patients