Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
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.
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase IB Sulindac Study for Women at High Risk for Breast Cancer|
- Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment [ Designated as safety issue: No ]
- Prostaglandin (PGE2) levels in NAF before and after 6 weeks of treatment [ Designated as safety issue: No ]
- NAG-1 induction and C-reactive protein (CRP) reduction before and after 6 weeks of treatment [ Designated as safety issue: No ]
- Magnitude of change and dose response of PGE2, NAG-1, and CRP in NAF before and after 6 weeks of treatment [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||January 2010|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
- 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.
|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|