Liver Safety Under Upfront Arimidex vs Tamoxifen

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

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.

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