Breast Cancer Clinical Trial
Official title:
Phase IB Sulindac Study for 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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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