Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00245024|
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : May 3, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: sulindac Other: laboratory biomarker analysis||Phase 1|
- 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.
- 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 and/or 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IB Sulindac Study for Women at High Risk for Breast Cancer|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||January 2010|
- Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
- Prostaglandin (PGE2) levels in NAF before and after 6 weeks of treatment
- NAG-1 induction and C-reactive protein (CRP) reduction before and after 6 weeks of treatment
- Magnitude of change and dose response of PGE2, NAG-1, and CRP in NAF before and after 6 weeks of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245024
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724-5024|
|Study Chair:||Patricia Thompson, PhD||University of Arizona|