Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer in situ, ductal breast carcinoma in situ
Eligibility Criteria
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
Sites / Locations
- Meharry Medical College
- Vanderbilt-Ingram Cancer Center