NCT01077453

Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer

Phase I Dose-Finding Trial of Letrozole in Postmenopausal Women at High Risk for Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy, no Evidence of Disease
• Lobular Breast Carcinoma in Situ

Interventions

Type	Name	Description
DRUG	letrozole	Given orally
OTHER	quality-of-life assessment	Ancillary studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-06-01
• First posted: 2010-03-01
• Last updated: 2014-10-20

Locations

3 sites across 1 country: United States