Breast CancerPhase 4HEARTNCT00537771

Liver Safety Under Upfront Arimidex vs Tamoxifen

A Phase 4 study testing Anastrozole and Tamoxifen in people with Breast Cancer, run by AstraZeneca at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Breast Cancer
What is being tested?: Anastrozole and Tamoxifen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 384 participants
Where: 16 sitesChina
Study dates: Sep 2007to Dec 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Histologically proven HR+ invasive breast cancer
Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
Postmenopausal woman

Who cannot join

clinical evidence of metastatic disease
previous adjuvant hormonal therapy for breast cancer
liver diseases

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

China16 sites

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

Other trials in China

About this study

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

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.

Conditions: Breast Cancer
Being tested: Anastrozole, Tamoxifen
Keywords: Early Breast cancer, adjuvant therapy, hormone receptor, hormonal therapy, anastrozole, tamoxifen
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AnastrozoleDrug
Also called ARIMIDEX, ZD1033
1 mg once daily oral dose
TamoxifenDrug
Also called NOLVADEX
20 mg once daily oral dose

Study groups in NCT00537771
Study group	Role	What they receive
1	Experimental	Anastrozole (ARIMIDEX) Receives: Drug: Anastrozole
2	Active comparator	Tamoxifen Receives: Drug: Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At 48 weeks, 96 weeks, 144 weeks

Secondary outcomes (2)

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.
Measured: At 48 weeks, 96 weeks, 144 weeks
Time to Treatment Failure
Measured: Within 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Dec 2011

First posted1 Oct 2007 (estimated)
Study startSep 2007
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 384 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00537771
Sponsor's protocol ID: D5392L00023
Acronym: HEART
Status last verified: Dec 2012
First submitted: 27 Sep 2007
Last updated: 25 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00537771
Acronym / sponsor ID: HEART / D5392L00023
Conditions: Breast Cancer
Keywords: Early Breast cancer, adjuvant therapy, hormone receptor, hormonal therapy, anastrozole, tamoxifen
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 384 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 1 Oct 2007 (estimated)
Results: Posted 25 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AnastrozoleAnastrozole (ARIMIDEX)
2	Active comparator	Drug: TamoxifenTamoxifen

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Histologically proven HR+ invasive breast cancer
Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
Postmenopausal woman

Key exclusion criteria (3 listed)

clinical evidence of metastatic disease
previous adjuvant hormonal therapy for breast cancer
liver diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AnastrozoleAlso: ARIMIDEX, ZD10331 mg once daily oral dose	Drug	1
TamoxifenAlso: NOLVADEX20 mg once daily oral dose	Drug	2

Primary outcome

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.

2 secondary outcomes

Incidence of Abnormal Liver Function
Time frame: At 48 weeks, 96 weeks, 144 weeks
Time to Treatment Failure
Time frame: Within 3 years

Results and safety

Results posted to the registry on 25 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arimidex Group	178	149
TAM Group	175	114

Primary outcome: Incidence of Fatty Liver Disease

Time frame: At 48 weeks, 96 weeks, 144 weeks. Number. Unit: participants

Measure	Arimidex Group n = 178	TAM Group n = 175
48 weeks	9	53
96 weeks	15	66
144 weeks	26	72

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arimidex Group	4 of 178 (2.2%)	39 of 178 (21.9%)	Not reported
TAM Group	4 of 175 (2.3%)	41 of 175 (23.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vivian Gu study director

AstraZeneca

Fengping Liang study chair

AstraZeneca

Prof. Wang Shenming principal investigator

AstraZeneca

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anastrozole and Tamoxifen in people with Breast Cancer, run by AstraZeneca at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Fatty Liver Disease (time frame: At 48 weeks, 96 weeks, 144 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00537771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.