Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082667
Status:
TERMINATED
Last Update Posted:
2013-02-25
First Post:
2004-05-14
Brief Title:
Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
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 15 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 15 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VICC-BRE-0249 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P30CA068485 | NIH | None | None |