Liver Safety Under Upfront Arimidex vs Tamoxifen

Breast Cancer Clinical Trial

— HEART  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537771
• Other study ID #: D5392L00023
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2007
• Last updated: December 20, 2012
• Start date: September 2007
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
1 mg once daily oral dose
• Tamoxifen
20 mg once daily oral dose

Locations

Country	Name	City	State
China	Research Site	Changchun	Jilin
China	Research Site	Chengdu	Sichuan
China	Research Site	Dalian	Liaoning
China	Research Site	Fuzhou	Fujian
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Jinan	Shandong
China	Research Site	Kunming	Yunnan
China	Research Site	Nanjing	Jiangsu
China	Research Site	Nanning	Guangxi
China	Research Site	Shanghai	Shanghai
China	Research Site	Taiyuan	Shanxi
China	Research Site	Tianjin
China	Research Site	Wuchang	Hubei
China	Research Site	Wuhan	Hubei
China	Research Site	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Fatty Liver Disease	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.	At 48 weeks, 96 weeks, 144 weeks	Yes
Secondary	Incidence of Abnormal Liver Function	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.	At 48 weeks, 96 weeks, 144 weeks	Yes
Secondary	Time to Treatment Failure		Within 3 years	Yes