NCT00579826

Study of Breast Cancer Prevention by Letrozole in High Risk Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Carol Fabian, MD · Academic / Other
• Sex: Female
• Age: 30 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of \>1.5%. The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.

Detailed description

Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third RPFNA and biomarker

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
DRUG	Placebo	Placebo tablet daily for 6 months then optional open label letrozole for 6 months.

Timeline

• Start date: 2006-10-01
• Primary completion: 2015-03-01
• Completion: 2018-08-01
• First posted: 2007-12-24
• Last updated: 2023-06-12
• Results posted: 2017-02-23

Locations

1 site across 1 country: United States