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.
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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivian Gu, Study director, AstraZenecaFengping Liang, Study chair, AstraZenecaProf. Wang Shenming, Principal investigator, AstraZeneca
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
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.
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.
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
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.
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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?
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.