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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
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
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