Study identifier:D5392L00023
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Breast Cancer
Phase 4
No
Anastrozole, Tamoxifen
Female
353
Interventional
N/A
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Verified 01 Dec 2012 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Guangzhou, Guangdong, China
Location
Shanghai, Shanghai, China
Location
Tianjin, China
Location
JINAN, Shandong, China
Location
Dalian, Liaoning, China
Location
CHENGDU, Sichuan, China
Location
FUZHOU, Fujian, China
Location
HANGZHOU, Zhejiang, China
Arms | Assigned Interventions |
---|---|
Experimental: 1 Anastrozole (ARIMIDEX) | Drug: Anastrozole 1 mg once daily oral dose Other Name: ARIMIDEX Other Name: ZD1033 |
Active Comparator: 2 Tamoxifen | Drug: Tamoxifen 20 mg once daily oral dose Other Name: NOLVADEX |
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