Breast Cancer Clinical Trial
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ductal carcinoma in situ.
PURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery works compared to surgery alone for the treatment of women with ductal carcinoma in situ of the breast.
Full Description
OBJECTIVES:
Primary
Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by local surgery.
Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs EGFR-negative patients.
Secondary
Compare the efficacy of these regimens in estrogen-receptor (ER)-positive vs ER-negative and in HER2-positive vs HER2-negative patients with DCIS.
Correlate levels of HER2 extracellular domain with biomarker modulation in patients treated with these regimens.
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral gefitinib once daily for 7-14 days or until the day before local surgery. Patients then undergo lumpectomy or mastectomy.
Arm II: Patients receive oral placebo once daily for 7-14 days or until the day before local surgery. Patients then undergo local surgery as in arm I.
PROJECTED ACCRUAL: A total of 78 patients (39 per treatment arm) will be accrued for this study within 1.5 years.
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
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There are 2 Locations for this study
Nashville Tennessee, 37208, United States
Nashville Tennessee, 37232, United States
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