Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088972
Status:
TERMINATED
Last Update Posted:
2018-08-10
First Post:
2004-08-04
Brief Title:
S0300 Celecoxib in Preventing Breast Cancer in Premenopausal Women
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of celecoxib may be effective in preventing breast cancer
PURPOSE This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease
PURPOSE This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease
Detailed Description:
OBJECTIVES
Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo
Compare 1-year proliferation of breast epithelial cells as measured by Ki67 staining in patients treated with these drugs
Compare the expression of other biomarkers including cyclo-oxygenase-2 COX-2 enzyme and a marker of apoptosis in breast tissue of patients treated with these drugs
Compare 1-year plasma levels of insulin-like growth factor IGF-1 IGF binding protein-3 and prostaglandin E_2 in patients treated with these drugs
Compare the toxicity of these drugs in these patients
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to risk category lobular carcinoma in situ or ductal carcinoma in situ vs BRCA12 mutation AND any Gail risk vs Gail risk 17 but 5 vs Gail risk 5 and prior tamoxifen use yes vs no Patients are randomized to 1 of 2 treatment arms
Celocoxib Patients receive oral celecoxib twice daily
Placebo Patients receive oral placebo twice daily In both arms treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo
Compare 1-year proliferation of breast epithelial cells as measured by Ki67 staining in patients treated with these drugs
Compare the expression of other biomarkers including cyclo-oxygenase-2 COX-2 enzyme and a marker of apoptosis in breast tissue of patients treated with these drugs
Compare 1-year plasma levels of insulin-like growth factor IGF-1 IGF binding protein-3 and prostaglandin E_2 in patients treated with these drugs
Compare the toxicity of these drugs in these patients
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to risk category lobular carcinoma in situ or ductal carcinoma in situ vs BRCA12 mutation AND any Gail risk vs Gail risk 17 but 5 vs Gail risk 5 and prior tamoxifen use yes vs no Patients are randomized to 1 of 2 treatment arms
Celocoxib Patients receive oral celecoxib twice daily
Placebo Patients receive oral placebo twice daily In both arms treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| U10CA012027 | NIH | None | None |
| S0300 | OTHER | None | None |
| U10CA037429 | NIH | SWOG | httpsreporternihgovquickSearchU10CA037429 |