Phase IB Sulindac Study for Women at High Risk for Breast Cancer
- 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
- 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
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Sulindac and sulindac metabolite levels in nipple aspirate fluid (NAF) after 6 weeks of treatment
Patricia Thompson, PhD
University of Arizona
United States: Federal Government
|Arizona Cancer Center at University of Arizona Health Sciences Center||Tucson, Arizona 85724|