Liver Safety Under Upfront Arimidex vs Tamoxifen (HEART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00537771
First received: September 27, 2007
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Anastrozole
Drug: Tamoxifen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of Fatty Liver Disease [ Time Frame: At 48 weeks, 96 weeks, 144 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Incidence of Abnormal Liver Function [ Time Frame: At 48 weeks, 96 weeks, 144 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Time to Treatment Failure [ Time Frame: Within 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 384
Study Start Date: September 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NOLVADEX

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537771

Locations
China, Fujian
Research Site
Fuzhou, Fujian, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Guangxi
Research Site
Nanning, Guangxi, China
China, Hubei
Research Site
Wuchang, Hubei, China
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Liaoning
Research Site
Dalian, Liaoning, China
China, Shandong
Research Site
Jinan, Shandong, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Taiyuan, Shanxi, China
Research Site
Xian, Shanxi, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Yunnan
Research Site
Kunming, Yunnan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
China
Research Site
Tianjin, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Vivian Gu AstraZeneca
Study Chair: Fengping Liang AstraZeneca
Principal Investigator: Prof. Wang Shenming AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00537771     History of Changes
Other Study ID Numbers: D5392L00023
Study First Received: September 27, 2007
Results First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Early Breast cancer
adjuvant therapy
hormone receptor
hormonal therapy
anastrozole
tamoxifen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014