At a glance
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Study of Breast Cancer Prevention by Letrozole in High Risk Women
In Brief
A Phase 2 clinical trial evaluating Letrozole and Placebo for Breast Cancer. Completed, enrolled 55 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.
Placebo tablet daily for 6 months then optional open label letrozole for 6 months.