At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 4,740 enrolled

Drug / intervention

Tamoxifen +1 moredrug

Likely dose

Exemestane 25 mg/day orally or continued Tamoxifen 20 mg/day orally for 2.5–3 yearsAI-extracted

Key inclusion· 4

✓Postmenopausal women
✓Histologically or cytologically confirmed primary breast adenocarcinoma
✓Received continuous tamoxifen for 2–3 years and one month
✓Currently disease-free

Key exclusion· 2

✕Unresectable breast cancer
✕ER-negative primary tumor

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

Search/NCT00038467

NCT00038467Phase 3Completed

Compare CT.gov

Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

Pfizer·interventional·Posted Jun 3, 2002·Updated May 7, 2014

In Brief

A Phase 3 clinical trial evaluating Tamoxifen and Exemestane for Breast Neoplasms. Completed, enrolled 4,740 participants across 377 sites in 37 countries.

Detailed Summary

To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Neoplasms

CountriesArgentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Luxembourg, Malta, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States

CollaboratorsInternational Collaborative Cancer Group

Timeline

Phase 3CompletedFinished

199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 1998

First PostedJun 2002

Primary CompletionJun 2003

Study CompletionMar 2013

TodayJul 2026

First PostedJun 3, 2002

Enrollment StartFeb 1, 1998

Primary CompletionJun 1, 2003

Study CompletionMar 1, 2013

TodayJul 2, 2026

Enrollment to primary: 5.3 yearsPosted 24.1 years ago

Interventions

Tamoxifendrug

Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Exemestanedrug

Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.