Conditions: Breast Cancer
Keywords: Early Breast cancer adjuvant therapy hormone receptor hormonal therapy anastrozole tamoxifen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 384
Healthy volunteers: no

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:

Arms:
arm 1: Anastrozole (ARIMIDEX) arm 2: Tamoxifen

Interventions: intervention 1: Anastrozole intervention 2: Tamoxifen
Intervention descriptions: intervention 1: 1 mg once daily oral dose intervention 2: 20 mg once daily oral dose

Protocol document: