Clinical trial · Observational
CARdiac Function Evaluation in Breast Cancer Patients
Longitudinal Characterisation of Cardiac Function in Recently-diagnosed Breast Cancer Patients
- 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)
This study will investigate the influence of systemic adjuvant/neoadjuvant therapy (SAT: chemotherapy +/- anti-HER2 antibodies (trastuzumab +/- pertuzumab) on heart function/rhythm and cardio-respiratory fitness in recently diagnosed breast cancer patients. In some patients, SAT damages the heart (so-called 'cardiotoxicity') and this can have a serious impact on the patient's quality of life and overall survival. It has also been suggested that anticancer therapies may lead to repolarization abnormalities, QT prolongation and autonomic dysfunction, clinically reflected by an increase in HR and a reduction in heart rate variability (HRV). There is a lack of information in the literature regarding the extent and time-course of changes in cardiac function, cardiac rhythm and cardio-respiratory performance ('fitness') in these patients. Moreover, the differential influences of specific treatment regimes (e.g. SAT or SAT plus radiotherapy) and different chemotherapy drugs on cardio-respiratory performance remain unclear. A better understanding of these issues is the primary aim of this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer Patients
- description
- Eligible participants will be women aged 18 years or over who have the following main characteristics: * Early invasive breast cancer (stage I-III) * Due to start SAT (adjuvant or neoadjuvant chemotherapy +/- trastuzumab +/- pertuzumab) * WHO performance status 0-2.
Primary outcomes (2)
- measure
- Cardiac Function (stroke volume or ejection fraction)
- timeFrame
- At completion of treatment, an average of 13 months
- description
- Cardiac function during/following treatment in breast cancer patients.
- measure
- Cardiac Rhythm (heart rate variability)
- timeFrame
- At completion of treatment, an average of 13 months
- description
- Cardiac rhythm during/following treatment in breast cancer patients.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Eligible participants will be women aged 18 years or over with the following characteristics: * Early invasive breast cancer (stage I-III) * Due to start adjuvant or neoadjuvant therapy including either anthracycline-based chemotherapy, or chemotherapy + trastuzumab +/- pertuzumab * WHO performance status \<=2 * Absence of major cardiovascular or chronic respiratory problems, or other conditions that in the opinion of the clinician would contraindicate the use of physical exercise assessments * Absence of contraindications for MRI scans, as listed in Paragraph 3.3. Patients unsuitable or unwilling to undergo MRI scans will be eligible for the study only if they are planned to receive trastuzumab, since this will include LVEF monitoring with MUGA scans or echocardiograms as part of routine care * Provision of signed informed consent. Exclusion Criteria: * Presence of major cardiovascular or chronic respiratory problems, or other conditions that in the opinion of the clinician would contraindicate the use of treadmill exercise assessments * Presence of contraindications for MRI scans: * Internal electronic devices such as neurostimulators or defibrillators * Replacement heart valve * Cardiac pacemaker * Intracranial vessel clips * Internal ear implant * Claustrophobia * Pregnancy. MRI scans will be requested by a clinician after the exclusion of the above contraindications. Patients unsuitable or unwilling to undergo MRI scans will be eligible for the study only if they are planned to receive trastuzumab, since this includes LVEF monitoring with MUGA scans or echocardiograms as part of routine care.
References
Publications (0)
Data not yet available