CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 3,966 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/NCT00382070
NCT00382070Phase 3Unknown

A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

NSABP Foundation Inc·interventional·Posted Sep 28, 2006·Updated Mar 22, 2024

In Brief

A Phase 3 clinical trial evaluating Letrozole and Placebo for Breast Cancer. Targeting 3,966 participants across 806 sites in 3 countries.

Detailed Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, Ireland, United States

Timeline

Phase 3UnknownOverdue
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2006
Enrollment StartAug 1, 2006
Primary CompletionAug 25, 2016
Study CompletionApr 1, 2025
TodayJul 1, 2026
Enrollment to primary: 10.1 yearsPosted 19.8 years ago

Interventions

Letrozoledrug

Letrozole 2.5 mg taken orally once daily for 5 years

Placeboother

Placebo tablet taken orally once daily for 5 years