Liver Safety Under Upfront Arimidex vs Tamoxifen (HEART)

December 20, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Research Site
    • Fujian
      • Fuzhou, Fujian, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Guangxi
      • Nanning, Guangxi, China
        • Research Site
    • Hubei
      • Wuchang, Hubei, China
        • Research Site
      • Wuhan, Hubei, China
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Site
    • Jilin
      • Changchun, Jilin, China
        • Research Site
    • Liaoning
      • Dalian, Liaoning, China
        • Research Site
    • Shandong
      • Jinan, Shandong, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
    • Shanxi
      • Taiyuan, Shanxi, China
        • Research Site
      • Xian, Shanxi, China
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Research Site
    • Yunnan
      • Kunming, Yunnan, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Anastrozole (ARIMIDEX)
Drug: Anastrozole
1 mg once daily oral dose
Other Names:
  • ARIMIDEX
  • ZD1033
Active Comparator: 2
Tamoxifen
Drug: Tamoxifen
20 mg once daily oral dose
Other Names:
  • NOLVADEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 48 weeks, 96 weeks, 144 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 48 weeks, 96 weeks, 144 weeks
Time to Treatment Failure
Time Frame: Within 3 years
Within 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Vivian Gu, AstraZeneca
  • Study Chair: Fengping Liang, AstraZeneca
  • Principal Investigator: Prof. Wang Shenming, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

January 25, 2013

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5392L00023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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