Liver Safety under upfront Arimidex vs Tamoxifen - HEART

Study identifier:D5392L00023

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Breast Cancer

Phase

Phase 4

Healthy volunteers

No

Study drug

Anastrozole, Tamoxifen

Sex

Female

Actual Enrollment

353

Study type

Interventional

Age

N/A

Date

Study Start Date: 01 Sept 2007
Primary Completion Date: 01 Dec 2011
Study Completion Date: 01 Dec 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Verification:

Verified 01 Dec 2012 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria