Study of Breast Cancer Prevention by Letrozole in High Risk Women
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
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.