Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00245024
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
- Secondary Outcome Measures
Name Time Method Magnitude of change and dose response of PGE2, NAG-1, and CRP in NAF before and 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
Trial Locations
- Locations (1)
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States