Study of Breast Cancer Prevention by Letrozole in High Risk Women

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.

Timeline

Start

2006-10

Primary completion

2015-03

Completion

2018-08

Outcome

Missed primary endpoint

registry analysis (unspecified test); Letrozole vs Placebo; p = 0.92; Wilcoxon (Mann-Whitney) NCT00579826 ↗

Drugs

Indications