Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
HER2BIC
A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
1 other identifier
interventional
220
1 country
4
Brief 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. The purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 12, 2022
CompletedFirst Posted
Study publicly available on registry
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
ExpectedApril 8, 2025
April 1, 2025
4.3 years
May 12, 2022
April 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricular ejection fraction (LVEF)
LVEF on cardiac MR.
Three months after treatment has ended.
Secondary Outcomes (6)
The number of treatment interruptions due to suspected cardiotoxicity
Through study completion, an average of 1 year.
The number of MUGA scans/echocardiograms
Through study completion, an average of 1 year.
The cumulative doses of trastuzumab and pertuzumab
After end of treatment, an average of 1 year after inclusion.
The proportion of patients treated for cardiotoxicity.
Through study completion, an average of 1 year
Change in self-reported health status measured with EQ-5D-5L questionnaire
At baseline, at treatment week 9, 18, 30 and 48 and three months after end of treatment.
- +1 more secondary outcomes
Other Outcomes (1)
Safty outcome of left ventricular ejection fraction
End of treatment
Study Arms (2)
Standard imaging monitored treatment
NO INTERVENTIONStandard care + biomarkers, which are blinded until end of study.
Intervention biomarker monitored treatment
EXPERIMENTALbiomarker monitored treatment + imaging, which is blinded until end of study
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Aarhus University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- University of Copenhagencollaborator
Study Sites (4)
Aalborg University Hospital
Aalborg, 9000, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev University Hospital
Herlev, Denmark
Odense University Hospital
Odense, 5000, Denmark
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Banke, MD PHD
Odense Universitetshospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Medical Doctor, PHD
Study Record Dates
First Submitted
May 12, 2022
First Posted
June 6, 2022
Study Start
October 1, 2021
Primary Completion
February 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share