Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
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|ClinicalTrials.gov Identifier: NCT00082667|
Recruitment Status : Terminated (PI left VICC)
First Posted : May 19, 2004
Last Update Posted : February 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: gefitinib Procedure: Surgery||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast|
|Study Start Date :||October 2002|
|Primary Completion Date :||July 2004|
|Study Completion Date :||June 2005|
- 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 surgery. [ Time Frame: at time of surgery, after 7-14 days of gefitinib ]
- Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patients [ Time Frame: at time of surgery, after 7-14 days of gefitinib ]
- Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCIS [ Time Frame: at time of surgery, after 7-14 days of gefitinib ]
- Correlate levels of HER2 extracellular domain in ER-positive vs. ER-negative and in HER2-positive cs. HER2-negative patients [ Time Frame: at time of surgery, after 7-14 days of gefitinib ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082667
|United States, Tennessee|
|Meharry Medical College|
|Nashville, Tennessee, United States, 37208|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Mayer Mayer, MD||Vanderbilt-Ingram Cancer Center|