Liver Safety Under Upfront Arimidex vs Tamoxifen

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole; Drug: Tamoxifen

• Registration Number: NCT00537771
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-10-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Results First Submitted: 2012-12-20
• Results First Submitted QC: 2012-12-20
• Last Update Submitted: 2012-12-20
• Results First Posted: 2013-01-25
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 384

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anastrozole	Anastrozole (ARIMIDEX)
2	Tamoxifen	Tamoxifen

Primary Outcome Measures

Name	Time	Method
Incidence of Fatty Liver Disease	At 48 weeks, 96 weeks, 144 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Abnormal Liver Function	At 48 weeks, 96 weeks, 144 weeks	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.
Time to Treatment Failure	Within 3 years

Trial Locations

Locations (1)

Research Site; 🇨🇳 Tianjin, China