CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Letrozole +1 moredrug
Likely dose
Letrozole 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00579826
NCT00579826Phase 2Completed

Study of Breast Cancer Prevention by Letrozole in High Risk Women

Carol Fabian, MD·interventional·Posted Dec 24, 2007·Updated Jun 12, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2007
Enrollment StartOct 1, 2006
Primary CompletionMar 1, 2015
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 18.5 years ago

Interventions

Letrozoledrug

Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.

Placebodrug

Placebo tablet daily for 6 months then optional open label letrozole for 6 months.