CardiotoxicityHER2BICNCT05406635
Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
A study testing Biomarkers: Troponins and natriuretic peptides in people with Cardiotoxicity and HER2-positive Breast Cancer, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
Due to a risk of heart failure during HER2 directed therapy in breast cancer, treatment is monitored with imaging of myocardial function, which is resource demanding for both patients and the health care system. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Cardiotoxicity, HER2-positive Breast Cancer
- What is being tested?
- Biomarkers: Troponins and natriuretic peptides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Oct 2021to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-metastatic HER2 positive breast cancer
- Scheduled for standard chemotherapy and HER2 directed therapy with trastuzumab +/- pertuzumab
- Age > 18 years
- Sinus rhythm on ECG
- NT-proBNP below125 pg/ml
- Troponin below threshold limit value
- LVEF > 55% by MUGA scan or an echocardiogram
Who cannot join
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 <80 % of predicted
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Rigshospitalet
Copenhagen
Odense University Hospital
Odense, 5000
About this study
Official title: A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Due to a risk of heart failure during HER2 directed therapy in breast cancer, treatment is monitored with imaging of myocardial function, which is resource demanding for both patients and the health care system. The purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
Read the detailed description
About 15% of breast cancer tumors express the Human Epidermal Growth Factor Receptor 2 (HER2), which is associated with a poor prognosis. Antibodies (trastuzumab and pertuzumab) directed against HER2 have in addition to traditional chemotherapy significantly improved survival in HER2 positive breast cancer, but induce a risk of left ventricular dysfunction and heart failure. Regular imaging based evaluation of myocardial function is therefore recommended during HER2 directed therapy by either an echocardiography or a MUGA scan, which is associated with radiation exposure. Both types of scans are resources demanding for both patients and the healthcare system, and since biomarkers have been proposed as another modality in assessment of myocardial injury, the purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
The study is designed as a national multicenter, randomized study, which will include Odense University Hospital, Herlev and Gentofte University Hospital and Aarhus University Hospital. It will be possible to include more sites.
Patients with localized HER2-positive breast cancer scheduled for HER2 proper therapy will be randomized 1: 1 to:
- Standard imaging monitored treatment as recommended by DBCG guidelines with measurement of LVEF by MUGA scan or echocardiography in weeks 0, 9, 18, 30 and 48 of the treatment period. At each control visit, biomarkers are also taken, which are blinded until the end of the study.
- Biomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period. At each of these follow-up visits, MUGA scans or echocardiography are also performed, but the results are blinded to the staff responsible for treatment decisions.
In the group followed by standard imaging monitoring, cardiotoxicity will be managed according to standard clinical guidelines. Cardiotoxicity in the biomarker group will be suspected in case of a doubling of NT-proBNP from baseline (but minimum 125 pg / ml) and / or an increase in troponins to above 99th percentile. If these criteria are met, imaging is triggered, which in practice is a blinding of the result of the examination already performed.
The primary endpoint of the study is LVEF measured by cardiac MRI scan three months after completion of HER2-directed therapy.
- Conditions
- Cardiotoxicity, HER2-positive Breast Cancer
- Being tested
- Biomarkers: Troponins and natriuretic peptides
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers: Troponins and natriuretic peptidesDiagnostic test
Biomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Standard imaging monitored treatment | No intervention | Standard care + biomarkers, which are blinded until end of study. |
| Intervention biomarker monitored treatment | Experimental | biomarker monitored treatment + imaging, which is blinded until end of study Receives: Diagnostic Test: Biomarkers: Troponins and natriuretic peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
LVEF on cardiac MR.
Measured: Three months after treatment has ended.
Secondary outcomes (6)
The number of treatment interruptions due to suspected cardiotoxicity
Number of times treatment was paused due to suspected cardiotoxicity either based on imaging or biomarkes as defined in the protocol.
Measured: Through study completion, an average of 1 year.
The number of MUGA scans/echocardiograms
The number of MUGA scans/echocardiograms preformed during the study periode.
Measured: Through study completion, an average of 1 year.
The cumulative doses of trastuzumab and pertuzumab
The cumulative doses of trastuzumab and pertuzumab in mg.
Measured: After end of treatment, an average of 1 year after inclusion.
The proportion of patients treated for cardiotoxicity.
Number of patients referred to tratment for heart failure in the department of cardiology.
Measured: Through study completion, an average of 1 year
Change in self-reported health status measured with EQ-5D-5L questionnaire
An Index score and a Visual Analogue Scale (VAS).
Measured: At baseline, at treatment week 9, 18, 30 and 48 and three months after end of treatment.
Correlation between radiotherapy and cardiac function.
Correlation between location and dose of the radiotherapy with changes in biomarkers, LVEF and ECG.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Oct 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Banke, Odense University Hospital
- Investigators
- Ann Banke, MD PHD, Principal investigator, Odense Universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406635
- Sponsor's protocol ID
- OP_1413
- Acronym
- HER2BIC
- Status last verified
- Oct 2026
- First submitted
- 12 May 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05406635
- Acronym / sponsor ID
- HER2BIC / OP_1413
- Conditions
- Cardiotoxicity, HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aalborg University Hospital, University of Copenhagen
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to a risk of heart failure during HER2 directed therapy in breast cancer, treatment is monitored with imaging of myocardial function, which is resource demanding for both patients and the health care system. The purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
Detailed description
About 15% of breast cancer tumors express the Human Epidermal Growth Factor Receptor 2 (HER2), which is associated with a poor prognosis. Antibodies (trastuzumab and pertuzumab) directed against HER2 have in addition to traditional chemotherapy significantly improved survival in HER2 positive breast cancer, but induce a risk of left ventricular dysfunction and heart failure. Regular imaging based evaluation of myocardial function is therefore recommended during HER2 directed therapy by either an echocardiography or a MUGA scan, which is associated with radiation exposure. Both types of scans are resources demanding for both patients and the healthcare system, and since biomarkers have been proposed as another modality in assessment of myocardial injury, the purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
The study is designed as a national multicenter, randomized study, which will include Odense University Hospital, Herlev and Gentofte University Hospital and Aarhus University Hospital. It will be possible to include more sites.
Patients with localized HER2-positive breast cancer scheduled for HER2 proper therapy will be randomized 1: 1 to:
- Standard imaging monitored treatment as recommended by DBCG guidelines with measurement of LVEF by MUGA scan or echocardiography in weeks 0, 9, 18, 30 and 48 of the treatment period. At each control visit, biomarkers are also taken, which are blinded until the end of the study.
- Biomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period. At each of these follow-up visits, MUGA scans or echocardiography are also performed, but the results are blinded to the staff responsible for treatment decisions.
In the group followed by standard imaging monitoring, cardiotoxicity will be managed according to standard clinical guidelines. Cardiotoxicity in the biomarker group will be suspected in case of a doubling of NT-proBNP from baseline (but minimum 125 pg / ml) and / or an increase in troponins to above 99th percentile. If these criteria are met, imaging is triggered, which in practice is a blinding of the result of the examination already performed.
The primary endpoint of the study is LVEF measured by cardiac MRI scan three months after completion of HER2-directed therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard imaging monitored treatment | No intervention | –Standard care + biomarkers, which are blinded until end of study. |
| Intervention biomarker monitored treatment | Experimental | Diagnostic Test: Biomarkers: Troponins and natriuretic peptidesbiomarker monitored treatment + imaging, which is blinded until end of study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with non-metastatic HER2 positive breast cancer
- Scheduled for standard chemotherapy and HER2 directed therapy with trastuzumab +/- pertuzumab
- Age > 18 years
- Sinus rhythm on ECG
- NT-proBNP below125 pg/ml
Key exclusion criteria (2 listed)
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 <80 % of predicted
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 |
|---|---|---|
| Biomarkers: Troponins and natriuretic peptidesBiomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period. | Diagnostic test | Intervention biomarker monitored treatment |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: Three months after treatment has ended.
LVEF on cardiac MR.
6 secondary outcomes
The number of treatment interruptions due to suspected cardiotoxicity
Time frame: Through study completion, an average of 1 year.
The number of MUGA scans/echocardiograms
Time frame: Through study completion, an average of 1 year.
The cumulative doses of trastuzumab and pertuzumab
Time frame: After end of treatment, an average of 1 year after inclusion.
The proportion of patients treated for cardiotoxicity.
Time frame: Through study completion, an average of 1 year
Change in self-reported health status measured with EQ-5D-5L questionnaire
Time frame: At baseline, at treatment week 9, 18, 30 and 48 and three months after end of treatment.
Correlation between radiotherapy and cardiac function.
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ann Banke, MD PHD principal investigator
Odense Universitetshospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarkers: Troponins and natriuretic peptides in people with Cardiotoxicity and HER2-positive Breast Cancer, run by Odense University Hospital at 3 sites in Denmark.
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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Left ventricular ejection fraction (LVEF) (time frame: Three months after treatment has ended.). 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 22 Oct 2026.