Clinical trial · Interventional
Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
NCT05406635CI-TRIAL-00088277HER2BICrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiotoxicity | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarkers: Troponins and natriuretic peptides | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard imaging monitored treatment
- description
- Standard care + biomarkers, which are blinded until end of study.
- type
- EXPERIMENTAL
- label
- Intervention biomarker monitored treatment
- description
- biomarker monitored treatment + imaging, which is blinded until end of study
- interventionNames
- Diagnostic Test: Biomarkers: Troponins and natriuretic peptides
Primary outcomes (1)
- measure
- Left ventricular ejection fraction (LVEF)
- timeFrame
- Three months after treatment has ended.
- description
- LVEF on cardiac MR.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Contra indications for cardiac magnetic resonance imaging (CMRI) * Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
References
Publications (0)
Data not yet available
No reference posted for this study.