Healthy, no Evidence of Disease Clinical Trial
Official title:
Phase I Dose-Finding Trial of Letrozole in Postmenopausal Women at High Risk for Breast Cancer
This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk for breast cancer.
PRIMARY OBJECTIVES:
I. Compare the effect of lower and intermittent doses of letrozole to standard letrozole
therapy on estrogen suppression in postmenopausal women at high risk for developing breast
cancer.
SECONDARY OBJECTIVES:
I. Comparison of the effect of lower and intermittent doses of letrozole to standard therapy
on signs and symptoms of estrogen deficiency, including menopausal symptoms, serum lipid
profile, and serum marker of bone turnover.
II. Comparison of the effect of lower and intermittent doses of letrozole to standard
therapy on nuclear chromatin abnormality of breast epithelial cells collected by random
periareolar fine needle aspiration (RPFNA).
TERTIARY OBJECTIVES:
I. Determine the prevalence of breast cancer stem cells in the fine needle breast aspirates
and explore the potential intervention effect on the prevalence of breast cancer stem cells.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive 2.5 mg of letrozole orally (PO) thrice weekly for 6 months.
ARM II: Patients receive 1.0 mg of letrozole PO thrice weekly for 6 months.
ARM III: Patients receive 0.25 mg of letrozole PO thrice weekly for 6 months.
ARM IV: Patients receive 2.5 mg of letrozole PO once daily for 6 months.
After completion of study treatment, patients are followed up at week 30.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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