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
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
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
- Research Site
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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
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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