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Liver Safety Under Upfront Arimidex vs Tamoxifen

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Active

Not specified

Pharmaceutical / Industry

D5392L00023
NCT00537771

Trial Description

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.

Eligibility Criteria

Inclusion Criteria:

Histologically proven HR+ invasive breast cancer

Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy

Postmenopausal woman

Exclusion Criteria:

clinical evidence of metastatic disease

previous adjuvant hormonal therapy for breast cancer

liver diseases

Trial Contact Information

Trial Lead Organizations/Sponsors

AstraZeneca Pharmaceuticals LP

Joyce Li

Study Director

Emily Huang

Study Chair

Prof. Wang Shenming

Principal Investigator

AstraZeneca China Clinical Study, Information		Ph: +86 21 52564555*5030
		Email: junliang.cai@astrazeneca.com

Trial Sites

China

Guangzhou

Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00537771
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.