At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 384 enrolled
Drug / intervention
Anastrozole +1 moredrug
Likely dose
Anastrozole 1 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.
A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepatotoxicity of ARIMIDEX Compared With Tamoxifen in Adjuvant Therapy in Postmenopausal Women With Hormone Receptor+ Early Breast Cancer
In Brief
A Phase 4 clinical trial evaluating Anastrozole and Tamoxifen for Breast Cancer. Completed, enrolled 384 participants across 16 sites.
Detailed Summary
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases. The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedOct 2007
Primary CompletionDec 2011
TodayJul 2026
First PostedOct 1, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.8 years ago
Interventions
Anastrozoledrug
1 mg once daily oral dose
Tamoxifendrug
20 mg once daily oral dose