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Brief Title: Liver Safety Under Upfront Arimidex vs Tamoxifen
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 ID: NCT00537771
Brief 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.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Research Site, Tianjin, , China
Name: Vivian Gu
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
Name: Fengping Liang
Affiliation: AstraZeneca
Role: STUDY_CHAIR
Name: Prof. Wang Shenming
Affiliation: AstraZeneca
Role: PRINCIPAL_INVESTIGATOR