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Liver Safety Under Upfront Arimidex vs Tamoxifen (HEART)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anastrozole
Tamoxifen
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Early Breast cancer, adjuvant therapy, hormone receptor, hormonal therapy, anastrozole, tamoxifen

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Anastrozole (ARIMIDEX)

Tamoxifen

Outcomes

Primary Outcome Measures

Incidence of Fatty Liver Disease
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
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

Full Information

First Posted
September 27, 2007
Last Updated
December 20, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00537771
Brief Title
Liver Safety Under Upfront Arimidex vs Tamoxifen
Acronym
HEART
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Early Breast cancer, adjuvant therapy, hormone receptor, hormonal therapy, anastrozole, tamoxifen

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Anastrozole (ARIMIDEX)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Tamoxifen
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Other Intervention Name(s)
ARIMIDEX, ZD1033
Intervention Description
1 mg once daily oral dose
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
NOLVADEX
Intervention Description
20 mg once daily oral dose
Primary Outcome Measure Information:
Title
Incidence of Fatty Liver Disease
Description
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.
Time Frame
At 48 weeks, 96 weeks, 144 weeks
Secondary Outcome Measure Information:
Title
Incidence of Abnormal Liver Function
Description
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 Frame
At 48 weeks, 96 weeks, 144 weeks
Title
Time to Treatment Failure
Time Frame
Within 3 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Gu
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fengping Liang
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Prof. Wang Shenming
Organizational Affiliation
AstraZeneca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Research Site
City
Wuchang
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Research Site
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Xian
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Research Site
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Research Site
City
Tianjin
Country
China

12. IPD Sharing Statement

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Liver Safety Under Upfront Arimidex vs Tamoxifen

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