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OpenTrials
Completed

NCT Number: NCT00537771

Liver Safety Under Upfront Arimidex vs Tamoxifen

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

1 mg once daily oral dose

Other names: ARIMIDEX, ZD1033

Tamoxifen

Drug

20 mg once daily oral dose

Other names: NOLVADEX

Primary outcomes

  1. Incidence of Fatty Liver Disease

    Time frame: 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 outcomes

  1. Incidence of Abnormal Liver Function

    Time frame: 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.

  2. Time to Treatment Failure

    Time frame: Within 3 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: HEART

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2007
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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