Liver Safety Under Upfront Arimidex vs Tamoxifen

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Anastrozole; Tamoxifen

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