At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 8,028 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/NCT00004205

NCT00004205Phase 3Completed

Compare CT.gov

A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors

ETOP IBCSG Partners Foundation·interventional·Posted Jan 27, 2003·Updated Dec 12, 2017

In Brief

A Phase 3 clinical trial evaluating letrozole and tamoxifen citrate for Breast Cancer. Completed, enrolled 8,028 participants across 3 sites in 3 countries.

Detailed Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. If is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesDenmark, France, Switzerland

CollaboratorsUNICANCER, Danish Breast Cancer Cooperative Group

Timeline

Phase 3CompletedFinished

199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 1998

First PostedJan 2003

Primary CompletionDec 2008

Study CompletionJun 2016

TodayJul 2026

First PostedJan 27, 2003

Enrollment StartMar 1, 1998

Primary CompletionDec 1, 2008

Study CompletionJun 30, 2016

TodayJul 2, 2026

Enrollment to primary: 10.8 yearsPosted 23.4 years ago

Interventions

letrozoledrug

Letrozole 2.5 mg daily oral administration.

tamoxifen citratedrug

Tamoxifen 20 mg daily oral administration.