Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
NCT ID: NCT05406635
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2021-10-01
2027-09-01
Brief Summary
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Detailed Description
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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:
1. 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.
2. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard imaging monitored treatment
Standard care + biomarkers, which are blinded until end of study.
No interventions assigned to this group
Intervention biomarker monitored treatment
biomarker monitored treatment + imaging, which is blinded until end of study
Biomarkers: Troponins and natriuretic peptides
Biomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period.
Interventions
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Biomarkers: Troponins and natriuretic peptides
Biomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
18 Years
90 Years
FEMALE
No
Sponsors
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Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
University of Copenhagen
OTHER
Odense University Hospital
OTHER
Responsible Party
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Ann Banke
Principal Investigator, Medical Doctor, PHD
Principal Investigators
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Ann Banke, MD PHD
Role: PRINCIPAL_INVESTIGATOR
Odense Universitetshospital
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Herlev University Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Link to study description af Open Patient data Explorative Network
Other Identifiers
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OP_1413
Identifier Type: -
Identifier Source: org_study_id
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