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Liver Safety Under Upfront Arimidex vs Tamoxifen

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Anastrozole (Drug); Tamoxifen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Vivian Gu, Study Director, Affiliation: AstraZeneca
Fengping Liang, Study Chair, Affiliation: AstraZeneca
Prof. Wang Shenming, Principal Investigator, Affiliation: AstraZeneca

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.

Clinical Details

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

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

Primary outcome: Incidence of Fatty Liver Disease

Secondary outcome:

Incidence of Abnormal Liver Function

Time to Treatment Failure

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Research Site, Tianjin, China

Research Site, Fuzhou, Fujian, China

Research Site, Guangzhou, Guangdong, China

Research Site, Nanning, Guangxi, China

Research Site, Wuchang, Hubei, China

Research Site, Wuhan, Hubei, China

Research Site, Nanjing, Jiangsu, China

Research Site, Changchun, Jilin, China

Research Site, Dalian, Liaoning, China

Research Site, Jinan, Shandong, China

Research Site, Shanghai, Shanghai, China

Research Site, Taiyuan, Shanxi, China

Research Site, Xian, Shanxi, China

Research Site, Chengdu, Sichuan, China

Research Site, Kunming, Yunnan, China

Research Site, Hangzhou, Zhejiang, China

Additional Information

Starting date: September 2007
Last updated: December 20, 2012

Page last updated: August 23, 2015

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