CardiotoxicityCARDIOTOXNCT04790266
Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
An observational study of Cardiotoxicity, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
Trial summary
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%) measured on CMR and ECHO over the time window of 12 months from… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiotoxicity
- What is being tested?
- Cardiac MRI
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2020to 14 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged ≥ 18 years with stage I-III breast cancer treated with radiation therapy and neo/adjuvant chemo/immunotherapy +/- aromatase inhibitor/tamoxifen/LhRh agonist. An ancillary study will enroll also stage 0 patients
Who may be able to join
- Written informed consent must be obtained before any assessment is performed
- Age ≥ 18 years at visit 1
- Performance status ECOG 0-1
- *Stage I-III histology proven breast cancer
- Treated with adjuvant radiotherapy and neo/adjuvant anthracycline and/or trastuzumab-based therapy +/- hormonal therapy
- Negative pregnancy test (plasma HCG) for all females of childbearing potential (i.e not permanently sterilised- post hysterectomy or tubal ligation status) In the ancillary study patients with stage 0 (DCIS) histology proven breast cancer will also be included.
Who cannot join
- Known metastatic spread of any cancer
- Known active or recurrent hepatic disorder (cirrhosis, hepatitis), ASAT/ALAT 2xULN
- Renal function decrease (eGFR < 30 ml/min)
- Known coronary artery disease
- Angina pectoris
- Positive or missing pregnancy test (pre- and perimenopausal women) at enrolment visit
- Patients with baseline LVEF <53% and GLS <15%
- Patients with pacemaker
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Oncology Institute of Italian Switzerland
Bellinzona, Canton Ticino, 6500
About this study
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%) measured on CMR and ECHO over the time window of 12 months from the end of radiation therapy.
Read the detailed description
Overall study schedule The Overall Study Schedule is summarized in the assessment schedule (appendix 1).
This study is composed of three subsequent phases: a Run-In Phase, a RT/Systemic Therapy Phase, a Follow-Up Phase.
Run-In Phase The Run-In Phase starts with the first visit (before any cancer treatment), when Screening/Enrollment procedure is performed. This phase will start once a patient has provided WIC to participate in the study and ends the day of treatment start.
Screening / Enrolment Visit Visit will be performed before the expected starting date of treatment.
After a WIC has been obtained from the patient, the patient will be visited by the Investigators and the following information will be gathered:
- Demographic Data (age, height, weight, BMI);
- Medical history (previous and concomitant diseases, previous therapies, family history of CVD);
- Concomitant Medication;
- Physical examination \& overall health assessment (including vital signs).
- Pregnancy test (pre- and perimenopausal women). The inclusion and exclusion criteria will be checked and, if the patient complies with all the Inclusion and Exclusion criteria, she will be enrolled into the study
A baseline assessment will be performed by the Investigator:
CMR, ECG and ECHO will be done at the participating centers The patient will be assigned to specific treatment (chemo/immunotherapy and adjuvant radiation therapy +/- aromatase inhibitor/tamoxifen/LhRh agonist). A standard of care treatment will be administered.
Radiotherapy/Systemic therapy Treatment Phase (specific Visit descriptions) SYSTEMIC TREATMENT Blood sample will be scheduled before and, if possible, 24 hours after chemotherapy administration.
- Patients treated with antracyclines regimens will be checked with ECG and ECHO at the end of treatment.
- Blood sample will be scheduled before Trastuzumab administration every three weeks and ECHO will be done after every 4 cycles (3 months).
RADIOTHERAPY For Technical details see appendix 3. Before starting RT patients will be checked clinically the first day of treatment and baseline tests will be done.
Biomarkers will be checked the first day and in the middle of RT. If a patient gets symptomatic heart failure during the treatment, or if LVEF decline greater than 10% points with a final LVEF <53% measured on Echo, the patient will be referred to the cardiologist for a specific treatment as described by guidelines
End of RT Group Patients treated with trastuzumab, will continue the treatment up to 1 year. Blood tests will be taken every three weeks and Echos will be done after every 4 cycles (3-week cycles).
Follow-Up Phase 2 weeks+/-3 days after the end of RT, blood sample will be taken. An ECHO and CMR will be done.
All patients will be checked 6 weeks after the end of radiotherapy for the study visit.
The following activities will be performed:
Blood sample for biomarkers. If hs-CRP ≥3mg/l, ECHO will be done. All patients will be followed at least until 10 years after the end of RT. Blood samples for measuring biomarkers and ECHO and CMR will be done 12 months after the end of RT.
Unscheduled Visit An unscheduled visit may occur at any time during the study, only for safety reason or for a premature discontinuation from the study.
- Conditions
- Cardiotoxicity
- Being tested
- Cardiac MRI
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Also called Echocardiography, Cardiotoxicity laboratory tests (troponin, Pro-BNP, hsCRP)
cCardiac MRI, ecocardiography and cardiotoxicity blood tests will be repeated as previously scheduled
What is being measured
The primary outcome is the main question the study is designed to answer.
CMR T2 mapping
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%).
Measured: Time window of 12 months from the end of radiation therapy
Secondary outcomes (10)
GLS
To detect GLS decrease >15% from baseline, measured on Echo over the time window of 12 months
Measured: Time window of 12 months from the end of radiation therapy
Myocardial edema
To assess the incidence of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy.
To assess the incidence of myocardial oedema on ECHO after radiation therapy and cardiotoxic systemic therapy.
Measured: Time window of 12 months from the end of radiation therapy
Biomarkers (Troponine, pro-BNP, hs-CRP) correlate with LVEF
To see if the changes in Troponine (ng/L) will correlate with LVEF measurements, assessed by ECHO. To see if the changes in Troponine (ng/L) will correlate with LVEF measurements, assessed by CMR.
To see if the changes in pro-BNP (ng/L) will correlate with LVEF measurements, assessed by ECHO.
To see if the changes in pro-BNP (ng/L) will correlate with LVEF measurements, assessed by CMR.
To see if the changes in hs-CRP (mg/L) will correlate with LVEF measurements, assessed by ECHO.
To see if the changes in hs-CRP (mg/L) will correlate with LVEF measurements, assessed by CMR.
Measured: Time window of 12 months from the end of radiation therapy
Biomarkers (Troponine, pro-BNP, hs-CRP) correlated with GLS
To see if the changes in Troponine (ng/L) will correlate with GLS measurements, assessed by ECHO.
To see if the changes in pro-BNP (ng/L) will correlate with GLS measurements, assessed by ECHO.
To see if the changes in hs-CRP (mg/L) will correlate with GLS measurements, assessed by ECHO.
Measured: Time window of 12 months from the end of radiation therapy
Time to biomarkers (Troponine, pro-BNP, hs-CRP) increase
To compare the time to the Troponine (ng/L) positivity to the time to the decrease in GLS >15% and/or decline of LVEF ≥10% points with a final LVEF <53% measured on Echo.
To compare the time to the pro-BNP (ng/L) positivity to the time to the decrease in GLS >15% and/or decline of LVEF ≥10% points with a final LVEF <53% measured on Echo.
To compare the time to the hs-CRP (mg/L) positivity to the time to the decrease in GLS >15% and/or decline of LVEF ≥10% points with a final LVEF <53% measured on Echo.
Measured: Time window of 12 months from the end of radiation therapy
Biomarkers (Troponine, pro-BNP, hs-CRP) predictors of cardiotoxicity
To see if the changes in Troponine (ng/L) will correlate with developement of cardiotoxicity, defined as by decline of LVEF ≥10% points with a final LVEF <53%.
To see if the changes in pro-BNP (ng/L) will correlate with developement of cardiotoxicity, defined as by decline of LVEF ≥10% points with a final LVEF <53%.
To see if the changes in hs-CRP (mg/L) will correlate with developement of cardiotoxicity, defined as by decline of LVEF ≥10% points with a final LVEF <53%.
Measured: Time window of 12 months from the end of radiation therapy
Major cardiovascular events
To detect major cardiovascular events (defined as acute myocardial infarction, hospitalization due to heart failure, atrial flutter/fibrillation, ventricular tachycardia) or death due cardiac problems during the follow up
Measured: follow-up
cardiac fibrosis
assess the role of fibrosis on CMR (T1 mapping with evaluation of extracellular volume) after cardiotoxic radiation therapy and systemic therapy in predicting the incidence of cardiotoxicity
Measured: through study completion, an average of 1 year
acute asymptomatic pericarditis
incidence of acute asymptomatic pericarditis after radiation therapy, measured on CMR
Measured: through study completion, an average of 1 year
cardiac edema
investigate if the area of the edema on CRM correlates with RT dose distribution
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start15 Sep 2020
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiocentro Ticino, North Estonia Medical Centre, Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor
- Investigators
- mariacarla Valli, Principal investigator, IOSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790266
- Sponsor's protocol ID
- 2019-01395CE3508
- Other IDs
- 2019
- Acronym
- CARDIOTOX
- Status last verified
- Nov 2025
- First submitted
- 23 Feb 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Borgonovo G, Vettus E, Greco A, Leo LA, Faletra FF, Klersy C, Curti M, Valli M. Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Patients With Breast Cancer: Protocol for a Multi-Institutional Prospective Study. JMIR Res Protoc. 2022 Apr 21;11(4):e31887. doi: 10.2196/31887.
PubMed 35451989
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04790266
- Acronym / sponsor ID
- CARDIOTOX / 2019-01395CE3508
- Conditions
- Cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- Cardiocentro Ticino, North Estonia Medical Centre, Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%) measured on CMR and ECHO over the time window of 12 months from the end of radiation therapy.
Detailed description
Overall study schedule The Overall Study Schedule is summarized in the assessment schedule (appendix 1).
This study is composed of three subsequent phases: a Run-In Phase, a RT/Systemic Therapy Phase, a Follow-Up Phase.
Run-In Phase The Run-In Phase starts with the first visit (before any cancer treatment), when Screening/Enrollment procedure is performed. This phase will start once a patient has provided WIC to participate in the study and ends the day of treatment start.
Screening / Enrolment Visit Visit will be performed before the expected starting date of treatment.
After a WIC has been obtained from the patient, the patient will be visited by the Investigators and the following information will be gathered:
- Demographic Data (age, height, weight, BMI);
- Medical history (previous and concomitant diseases, previous therapies, family history of CVD);
- Concomitant Medication;
- Physical examination \& overall health assessment (including vital signs).
- Pregnancy test (pre- and perimenopausal women). The inclusion and exclusion criteria will be checked and, if the patient complies with all the Inclusion and Exclusion criteria, she will be enrolled into the study
A baseline assessment will be performed by the Investigator:
CMR, ECG and ECHO will be done at the participating centers The patient will be assigned to specific treatment (chemo/immunotherapy and adjuvant radiation therapy +/- aromatase inhibitor/tamoxifen/LhRh agonist). A standard of care treatment will be administered.
Radiotherapy/Systemic therapy Treatment Phase (specific Visit descriptions) SYSTEMIC TREATMENT Blood sample will be scheduled before and, if possible, 24 hours after chemotherapy administration.
- Patients treated with antracyclines regimens will be checked with ECG and ECHO at the end of treatment.
- Blood sample will be scheduled before Trastuzumab administration every three weeks and ECHO will be done after every 4 cycles (3 months).
RADIOTHERAPY For Technical details see appendix 3. Before starting RT patients will be checked clinically the first day of treatment and baseline tests will be done.
Biomarkers will be checked the first day and in the middle of RT. If a patient gets symptomatic heart failure during the treatment, or if LVEF decline greater than 10% points with a final LVEF <53% measured on Echo, the patient will be referred to the cardiologist for a specific treatment as described by guidelines
End of RT Group Patients treated with trastuzumab, will continue the treatment up to 1 year. Blood tests will be taken every three weeks and Echos will be done after every 4 cycles (3-week cycles).
Follow-Up Phase 2 weeks+/-3 days after the end of RT, blood sample will be taken. An ECHO and CMR will be done.
All patients will be checked 6 weeks after the end of radiotherapy for the study visit.
The following activities will be performed:
Blood sample for biomarkers. If hs-CRP ≥3mg/l, ECHO will be done. All patients will be followed at least until 10 years after the end of RT. Blood samples for measuring biomarkers and ECHO and CMR will be done 12 months after the end of RT.
Unscheduled Visit An unscheduled visit may occur at any time during the study, only for safety reason or for a premature discontinuation from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged ≥ 18 years with stage I-III breast cancer treated with radiation therapy and neo/adjuvant chemo/immunotherapy +/- aromatase inhibitor/tamoxifen/LhRh agonist. An ancillary study will enroll also stage 0 patients
Key inclusion criteria (6 listed)
- Written informed consent must be obtained before any assessment is performed
- Age ≥ 18 years at visit 1
- Performance status ECOG 0-1
- *Stage I-III histology proven breast cancer
- Treated with adjuvant radiotherapy and neo/adjuvant anthracycline and/or trastuzumab-based therapy +/- hormonal therapy
Key exclusion criteria (8 listed)
- Known metastatic spread of any cancer
- Known active or recurrent hepatic disorder (cirrhosis, hepatitis), ASAT/ALAT 2xULN
- Renal function decrease (eGFR < 30 ml/min)
- Known coronary artery disease
- Angina pectoris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIAlso: Echocardiography, Cardiotoxicity laboratory tests (troponin, Pro-BNP, hsCRP)cCardiac MRI, ecocardiography and cardiotoxicity blood tests will be repeated as previously scheduled | Diagnostic test | – |
Primary outcome
CMR T2 mapping
Time frame: Time window of 12 months from the end of radiation therapy
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%).
10 secondary outcomes
GLS
Time frame: Time window of 12 months from the end of radiation therapy
Myocardial edema
Time frame: Time window of 12 months from the end of radiation therapy
Biomarkers (Troponine, pro-BNP, hs-CRP) correlate with LVEF
Time frame: Time window of 12 months from the end of radiation therapy
Biomarkers (Troponine, pro-BNP, hs-CRP) correlated with GLS
Time frame: Time window of 12 months from the end of radiation therapy
Time to biomarkers (Troponine, pro-BNP, hs-CRP) increase
Time frame: Time window of 12 months from the end of radiation therapy
Biomarkers (Troponine, pro-BNP, hs-CRP) predictors of cardiotoxicity
Time frame: Time window of 12 months from the end of radiation therapy
Major cardiovascular events
Time frame: follow-up
cardiac fibrosis
Time frame: through study completion, an average of 1 year
acute asymptomatic pericarditis
Time frame: through study completion, an average of 1 year
cardiac edema
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 35451989Borgonovo G, Vettus E, Greco A, Leo LA, Faletra FF, Klersy C, Curti M, Valli M. Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Patients With Breast Cancer: Protocol for a Multi-Institutional Prospective Study. JMIR Res Protoc. 2022 Apr 21;11(4):e31887. doi: 10.2196/31887.
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3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
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Assessment of The Potential Therapeutic Effects of Trimetazidine on Aluminium Phosphide-Induced Cardiotoxicity as an Adjuvant Therapy: A Pilot Study
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The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mariacarla Valli principal investigator
IOSI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMR T2 mapping (time frame: Time window of 12 months from the end of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.