Liver Safety Under Upfront Arimidex vs Tamoxifen (HEART)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Tamoxifen; Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537771

D5392L00023

Details and patient eligibility

About

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.

Enrollment: 384 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 2 patient groups

1

Experimental group

Description:

Anastrozole (ARIMIDEX)

Treatment:

Drug: Anastrozole

2

Active Comparator group

Description:

Tamoxifen

Treatment:

Drug: Tamoxifen