Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT00082667
Status:
TERMINATED
Last Update Posted:
2013-02-25
First Post:
2004-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left VICC
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VICC-BRE-0249 | None | None | View |