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



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

For Condition: breast cancer in situ,intraductal breast carcinoma
Status: Recruiting
Sponsor(s): Vanderbilt-Ingram Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to study the effectiveness of gefitinib followed by lumpectomy or mastectomy in treating women who have ductal carcinoma in situ of the breast.
Details: 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. Tertiary - 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 35 Years/
Genders: Both
Protocol Entry 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 nonapproved 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 - Neflinavir - Nevirapine - Oxcarbazepine - Phenylbutazone - Primidone - Rifabutin - Rofecoxib - Sulfamethazine - Sulfinpyrazone - Troglitazone - No concurrent antiretroviral treatment for HIV-positive patients
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CristinaTruica,  Principal Investigator,  Vanderbilt-Ingram Cancer Center

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-6838
United States
Recruiting Cristina  Truica 615-936-3831


Additional Information:
Study ID Numbers:  CDR0000355152;  VICC-BRE-0249
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082667

Other Intraductal Breast Carcinoma Studies:
1. Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer Who Are Eligible For Tamoxifen Therapy

2. Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

3. Anastrozole Compared With Tamoxifen After Lumpectomy in Treating Postmenopausal Women With Ductal Carcinoma in Situ

4. Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole

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

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