CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,172 enrolled
Drug / intervention
Letrozole +1 moredrug
Likely dose
Letrozole 2.5 mg orally once daily or Anastrozole 1 mg orally once dailyAI-extracted
Key inclusion· 5
  • Recent primary surgery for breast cancer
  • Early stage breast cancer
  • Postmenopausal status
  • Hormone receptor positive disease
Key exclusion· 3
  • Metastatic disease
  • Contralateral breast cancer including DCIS
  • Disease progression

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

Search/NCT00248170
NCT00248170Phase 3Completed

Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

Novartis Pharmaceuticals·interventional·Posted Nov 3, 2005·Updated Apr 19, 2016

In Brief

A Phase 3 clinical trial evaluating Letrozole and Anastrozole for Breast Cancer. Completed, enrolled 4,172 participants across 259 sites in 20 countries.

Detailed Summary

Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Canada, China, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 2005
Enrollment StartDec 1, 2005
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.7 years ago

Interventions

Letrozoledrug

2.5 mg tablets

Anastrozoledrug

1 mg tablets