Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245024
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2005-10-25
Brief Title:
Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IB Sulindac Study for Women at High Risk for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-10
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 is the use of certain drugs to keep cancer from forming growing or coming back The use of sulindac may prevent breast cancer
PURPOSE This randomized phase I trial is studying the effects of sulindac to prevent breast cancer in women at high risk for breast cancer
PURPOSE This randomized phase I trial is studying the effects of sulindac to prevent breast cancer in women at high risk for breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the partitioning of sulindac and its metabolites in women at high risk for breast cancer by measuring drug and metabolite levels in nipple aspirate fluid NAF after 6 weeks of therapy
Secondary
Determine prostaglandin levels in the NAF of patients treated with this drug
Determine if NAG-1 levels are induced in the NAF of patients treated with this drug
Determine if C-reactive protein levels are reduced in the NAF of patients treated with this drug
Determine if NAG-1 levels andor karyometric features in ductal epithelial cells are modulated in patients treated with this drug
OUTLINE This is a randomized open-label study
Patients undergo nipple aspirate fluid NAF collection Patients are then randomized to 1 of 2 treatment arms
Arm I Patients receive oral sulindac once daily
Arm II Patients receive oral sulindac twice daily In both arms treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity All patients then undergo a second NAF collection
After completion of study treatment patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 30 patients 15 per treatment arm will be accrued for this study
Primary
Determine the partitioning of sulindac and its metabolites in women at high risk for breast cancer by measuring drug and metabolite levels in nipple aspirate fluid NAF after 6 weeks of therapy
Secondary
Determine prostaglandin levels in the NAF of patients treated with this drug
Determine if NAG-1 levels are induced in the NAF of patients treated with this drug
Determine if C-reactive protein levels are reduced in the NAF of patients treated with this drug
Determine if NAG-1 levels andor karyometric features in ductal epithelial cells are modulated in patients treated with this drug
OUTLINE This is a randomized open-label study
Patients undergo nipple aspirate fluid NAF collection Patients are then randomized to 1 of 2 treatment arms
Arm I Patients receive oral sulindac once daily
Arm II Patients receive oral sulindac twice daily In both arms treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity All patients then undergo a second NAF collection
After completion of study treatment patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 30 patients 15 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 |
|---|---|---|---|
| UARIZ-HSC-0553 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023074 |
| P30CA023074 | NIH | None | None |
| UARIZ-UAZ04-2-02 | None | None | None |