An observational study in Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer and Breast Cancer, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Region Skane · Observational
Some cancer treatments, such as anthracycline chemotherapy and HER2-targeted therapy, can damage the heart (cardiotoxicity). If heart damage is detected early, heart-protective treatment can be started and cancer treatment can often continue without interruption.
Heart ultrasound (echocardiography) is the standard method for monitoring the heart during cancer treatment. Today, heart function is mainly assessed with two-dimensional (2D) measurements, which may miss early changes. A newer technique, three-dimensional speckle-tracking echocardiography (3D strain), follows the heart muscle's movement in all directions and may detect damage earlier and more accurately.
The SAFE HEART study will investigate whether 3D strain detects early heart damage better than 2D strain and conventional measures of pumping function (ejection fraction) in adults with breast cancer, lymphoma or sarcoma who are treated with anthracyclines and/or HER2-targeted therapy at Skåne University Hospital in Lund and Malmö, Sweden.
Participants undergo heart ultrasound, ECG and blood tests for cardiac biomarkers (troponin I and NT-proBNP) before, during and after cancer treatment. Blood samples are also stored in a biobank to search for new markers that can predict heart damage. Participants who develop signs of heart damage, and a matched group without heart damage, may be asked to undergo a cardiac magnetic resonance (MRI) scan.
Background: Cancer therapy-related cardiac dysfunction (CTRCD) is a major complication of anthracycline and HER2-targeted therapy and may lead to interruption of potentially curative cancer treatment. Left ventricular ejection fraction (LVEF) lacks sensitivity for subclinical myocardial injury. 2D global longitudinal strain (GLS) is recommended in the 2022 ESC Cardio-Oncology Guidelines for early detection of subclinical dysfunction, and the guidelines favour 3D echocardiography, but clinical evidence for 3D speckle-tracking echocardiography (3D-STE) remains limited. 3D-STE allows tracking of speckles in all directions, including out-of-plane motion, and simultaneous assessment of longitudinal, circumferential, radial and area strain from a single volumetric dataset. Right ventricular involvement in cardiotoxicity is also insufficiently studied.
Design: Prospective, observational, two-centre cohort study at Skåne University Hospital (Lund and Malmö), Sweden. Consecutive adult patients referred for baseline echocardiography before anthracycline and/or HER2-targeted therapy for breast cancer, lymphoma or sarcoma are invited to participate.
Study procedures: Echocardiography including 2D and 3D acquisitions is performed according to a standardised protocol. 3D strain (left and right ventricle) and 3D LVEF are analysed using vendor-integrated software. Echocardiography and cardiac biomarkers (high-sensitivity troponin I and NT-proBNP) are obtained at the following time points:
Biobank: Blood samples (EDTA and serum) are collected at baseline and approximately 6 months after treatment start and stored in Region Skåne Biobank for future biomarker analyses.
Cardiac MRI sub-study: Approximately 20-25 participants with echocardiographic or biomarker evidence of cardiac injury and 20-25 matched participants without cardiac injury from the same cohort are asked to undergo contrast-enhanced cardiac MRI for tissue characterisation.
Clinical outcomes: Initiation of heart failure medication, heart failure hospitalisation and all-cause mortality are retrieved from Region Skåne health records and national Swedish registers.
Ethics: Approved by the Swedish Ethical Review Authority (Dnr 2024-06788-01; amendment 2025-05980-02).
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 130 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult patients with breast cancer, lymphoma or sarcoma who are referred for baseline echocardiography before starting anthracycline and/or HER2-targeted therapy at the echocardiography laboratories of Skåne University Hospital in Lund (Department of Cardiology) and Malmö (Department of Clinical Physiology), Sweden. Patients are identified through echocardiography referrals from the oncology and haematology departments and invited to participate at the time of the baseline examination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with breast cancer scheduled for anthracycline and/or HER2-targeted therapy. 2D and 3D echocardiography and cardiac biomarkers (troponin I, NT-proBNP) at baseline and thereafter according to clinical indication, typically every 3-4 months. Biobank samples at baseline and approximately 6 months.
Adults with lymphoma or sarcoma scheduled for anthracycline-based therapy. 2D and 3D echocardiography and cardiac biomarkers (troponin I, NT-proBNP) at baseline, 6 months and 24 months after treatment start. Biobank samples at baseline and approximately 6 months.
Change in 3D left ventricular strain parameters compared with 2D global longitudinal strain during follow-up
Relative change (%) from baseline in left ventricular strain parameters measured by 3D speckle-tracking echocardiography (global longitudinal strain, global circumferential strain, global radial strain and global area strain), compared with the relative change in global longitudinal strain measured by 2D speckle-tracking echocardiography in the same patients at each follow-up examination.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Change in 3D left ventricular ejection fraction compared with 2D left ventricular ejection fraction
Relative change (%) from baseline in right ventricular free wall longitudinal strain measured by speckle-tracking echocardiography.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Change in right ventricular free wall longitudinal strain
Relative change (%) from baseline in right ventricular strain (free wall and global longitudinal strain) and 3D right ventricular ejection fraction measured by echocardiography.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Incidence of cancer therapy-related cardiac dysfunction (CTRCD)
Proportion of participants developing asymptomatic or symptomatic CTRCD according to the 2022 ESC Cardio-Oncology Guidelines definitions, based on LVEF, 2D GLS and cardiac biomarkers.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Area under the receiver operating characteristic curve of early change in 3D strain parameters for prediction of CTRCD
Area under the receiver operating characteristic curve (AUC) for early relative change (%) in 3D left ventricular strain parameters measured by 3D speckle-tracking echocardiography, compared with 2D global longitudinal strain and left ventricular ejection fraction, for prediction of subsequent CTRCD according to the 2022 ESC Cardio-Oncology Guidelines.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Correlation between change in 3D and 2D strain parameters and change in high-sensitivity troponin I
Spearman correlation coefficient between the relative change (%) from baseline in left ventricular strain parameters measured by 3D speckle-tracking echocardiography (global longitudinal, circumferential, radial and area strain) and 2D global longitudinal strain measured by 2D speckle-tracking echocardiography, and the change from baseline in plasma concentration of high-sensitivity troponin I (ng/L), measured by laboratory immunoassay.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Proportion of echocardiographic examinations with image quality adequate for 3D strain analysis
Percentage of echocardiographic examinations in which image quality is adequate for analysis of left ventricular strain by 3D speckle-tracking echocardiography, compared with the percentage adequate for 2D speckle-tracking echocardiography.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Correlation between 3D strain parameters and cardiac magnetic resonance measures
Spearman correlation coefficient between left ventricular strain parameters measured by 3D speckle-tracking echocardiography (global longitudinal, circumferential, radial and area strain, %) and cardiac magnetic resonance measures: left ventricular ejection fraction (%), native T1 (ms), T2 (ms), extracellular volume (%) and extent of late gadolinium enhancement (% of left ventricular mass), in participants with and without evidence of cardiac injury.
Time frame: Up to 24 months after start of cancer therapy
Number of participants with initiation of heart failure medication, hospitalisation for heart failure or all-cause death
Number of participants with at least one of the following events: initiation of heart failure medication, hospitalisation for heart failure or death from any cause, retrieved from Region Skåne health records and national Swedish registers.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Correlation between change in 3D and 2D strain parameters and change in NT-proBNP
Spearman correlation coefficient between the relative change (%) from baseline in left ventricular strain parameters measured by 3D speckle-tracking echocardiography (global longitudinal, circumferential, radial and area strain) and 2D global longitudinal strain measured by 2D speckle-tracking echocardiography, and the change from baseline in plasma concentration of NT-proBNP (ng/L), measured by laboratory immunoassay.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Change in 3D right ventricular ejection fraction
Absolute change (percentage points) from baseline in right ventricular ejection fraction measured by 3D echocardiography.
Time frame: From baseline (before start of cancer therapy) through 12 months of follow-up (breast cancer) and 24 months of follow-up (lymphoma and sarcoma)
Plan to share: No — Individual participant data will not be shared publicly due to Swedish and EU data protection regulations (GDPR) and the conditions of the ethical approval, which do not permit transfer of personal data outside the research group. De-identified data may be made available to qualified researchers upon reasonable request to the principal investigator, subject to approval by the Swedish Ethical Review Authority and a data sharing agreement.
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Dec 2028, 46 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 46 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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