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Liver Safety Under Upfront Arimidex vs Tamoxifen

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00537771
Acronym
HEART
Enrollment
384
Registered
2007-10-01
Start date
2007-09-30
Completion date
2011-12-31
Last updated
2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Early Breast cancer, adjuvant therapy, hormone receptor, hormonal therapy, anastrozole, tamoxifen

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.

Interventions

DRUGAnastrozole

1 mg once daily oral dose

DRUGTamoxifen

20 mg once daily oral dose

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Fatty Liver DiseaseAt 48 weeks, 96 weeks, 144 weeksThe 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

MeasureTime frameDescription
Incidence of Abnormal Liver FunctionAt 48 weeks, 96 weeks, 144 weeksThe 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 FailureWithin 3 years—

Countries

China

Participant flow

Recruitment details

Patients were enrolled in 28 centres in the People's Republic of China. FSI: 18Sep2007; LSI: 28 Feb2009;LSLV:20 Dec 2011.

Pre-assignment details

A total of 384 patients were screened (informed consent signed and CRF started) and 353 patients were randomized with 175 patients in the Tamoxifen group and 178 in the Arimidex group.

Participants by arm

ArmCount
Arimidex Group
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
178
TAM Group
Tamoxifen : 20 mg once daily oral dose
175
Total353

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event815
Overall StudyLost to Follow-up915
Overall StudyProtocol Violation26
Overall StudySevere Non-Compliance to Protocol42
Overall StudyWithdrawal by Subject623

Baseline characteristics

CharacteristicArimidex GroupTAM GroupTotal
Age Continuous59.7 years
STANDARD_DEVIATION 7.77
59.4 years
STANDARD_DEVIATION 8.84
59.6 years
STANDARD_DEVIATION 8.31
Sex: Female, Male
Female
178 Participants175 Participants353 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
39 / 17841 / 175
serious
Total, serious adverse events
4 / 1784 / 175

Outcome results

Primary

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.

Time frame: At 48 weeks, 96 weeks, 144 weeks

ArmMeasureGroupValue (NUMBER)
Arimidex GroupIncidence of Fatty Liver Disease48 weeks9 participants
Arimidex GroupIncidence of Fatty Liver Disease96 weeks15 participants
Arimidex GroupIncidence of Fatty Liver Disease144 weeks26 participants
TAM GroupIncidence of Fatty Liver Disease48 weeks53 participants
TAM GroupIncidence of Fatty Liver Disease96 weeks66 participants
TAM GroupIncidence of Fatty Liver Disease144 weeks72 participants
Secondary

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 frame: At 48 weeks, 96 weeks, 144 weeks

ArmMeasureGroupValue (NUMBER)
Arimidex GroupIncidence of Abnormal Liver Function48 weeks29 participants
Arimidex GroupIncidence of Abnormal Liver Function96 weeks37 participants
Arimidex GroupIncidence of Abnormal Liver Function144 weeks44 participants
TAM GroupIncidence of Abnormal Liver Function48 weeks36 participants
TAM GroupIncidence of Abnormal Liver Function96 weeks40 participants
TAM GroupIncidence of Abnormal Liver Function144 weeks43 participants
Secondary

Time to Treatment Failure

Time frame: Within 3 years

ArmMeasureValue (MEDIAN)
Arimidex GroupTime to Treatment Failure1112 days
TAM GroupTime to Treatment Failure454 days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026