Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056082
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2003-03-06
Brief Title:
Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
A Study to Identify Biomarker Modulation by a Cyclooxygenase-2 COX-2 Inhibitor in Breast Tissue of Premenopausal Women at High Risk for Estrogen Receptor Negative ERN Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer Celecoxib may be effective in preventing breast cancer in at-risk women
PURPOSE Phase II trial to study the effectiveness of celecoxib in preventing breast cancer in premenopausal women who are at risk of developing cancer
PURPOSE Phase II trial to study the effectiveness of celecoxib in preventing breast cancer in premenopausal women who are at risk of developing cancer
Detailed Description:
OBJECTIVES
Determine the change in proliferation in benign breast epithelial cells as measured by Ki-67MIB-1 in premenopausal women at high risk for estrogen receptor-negative breast cancer treated with celecoxib
Determine the feasibility of this regimen by dropout rate of these patients during 12 months of treatment and compliance
Determine the proportion of these women likely to express cyclooxygenase-2 protein COX-2 in at least 10 of benign ductal epithelial cells
Compare the success rate of obtaining adequate ductal epithelial cells by random periareolar fine needle aspiration FNA and ductal lavage in these patients before vs after 12 months of a prevention intervention
Assess pain associated with FNA and ductal lavage in these women
Correlate if possible serum proteomics pattern with cytologic assessment and mammographic density at baseline and at 12 months in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral celecoxib twice daily Treatment continues for 12 months in the absence of clinical evidence of cancer confirmed by biopsy or unacceptable toxicity
Patients are assessed at baseline and at 12 months for mammographic breast density serum hormone levels and serum IGF-1IGFBP-3 Patients undergo ductal lavage or fine needle aspiration for assessment of supernatant proteomics and breast biomarkers
Patients are followed at 2 weeks and then annually for 5 years
PROJECTED ACCRUAL A total of 110 patients will be accrued for this study within 10-14 months
Determine the change in proliferation in benign breast epithelial cells as measured by Ki-67MIB-1 in premenopausal women at high risk for estrogen receptor-negative breast cancer treated with celecoxib
Determine the feasibility of this regimen by dropout rate of these patients during 12 months of treatment and compliance
Determine the proportion of these women likely to express cyclooxygenase-2 protein COX-2 in at least 10 of benign ductal epithelial cells
Compare the success rate of obtaining adequate ductal epithelial cells by random periareolar fine needle aspiration FNA and ductal lavage in these patients before vs after 12 months of a prevention intervention
Assess pain associated with FNA and ductal lavage in these women
Correlate if possible serum proteomics pattern with cytologic assessment and mammographic density at baseline and at 12 months in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral celecoxib twice daily Treatment continues for 12 months in the absence of clinical evidence of cancer confirmed by biopsy or unacceptable toxicity
Patients are assessed at baseline and at 12 months for mammographic breast density serum hormone levels and serum IGF-1IGFBP-3 Patients undergo ductal lavage or fine needle aspiration for assessment of supernatant proteomics and breast biomarkers
Patients are followed at 2 weeks and then annually for 5 years
PROJECTED ACCRUAL A total of 110 patients will be accrued for this study within 10-14 months
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 |
|---|---|---|---|
| N01-CN-15135 | OTHER_GRANT | NCI | None |
| CDR0000271935 | REGISTRY | None | None |