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Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients (CARDIOTOX)

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ClinicalTrials.gov Identifier: NCT04790266
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Collaborators:
Cardiocentro Ticino
North Estonia Medical Centre
Fondazione IRCCS Policlinico San Matteo di Pavia
Information provided by (Responsible Party):
Oncology Institute of Southern Switzerland

Brief 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 the end of radiation therapy.

Condition or disease Intervention/treatment
Cardiotoxicity Diagnostic Test: Cardiac MRI

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Cardiac MRI
    cCardiac MRI, ecocardiography and cardiotoxicity blood tests will be repeated as previously scheduled
    Other Names:
    • Echocardiography
    • Cardiotoxicity laboratory tests (troponin, Pro-BNP, hsCRP)


Primary Outcome Measures :
  1. 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%).


Secondary Outcome Measures :
  1. GLS [ Time Frame: Time window of 12 months from the end of radiation therapy ]
    To detect GLS decrease >15% from baseline, measured on Echo over the time window of 12 months

  2. Myocardial edema [ Time Frame: Time window of 12 months from the end of radiation therapy ]

    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.


  3. Biomarkers (Troponine, pro-BNP, hs-CRP) correlate with LVEF [ Time Frame: Time window of 12 months from the end of radiation therapy ]

    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.


  4. Biomarkers (Troponine, pro-BNP, hs-CRP) correlated with GLS [ Time Frame: Time window of 12 months from the end of radiation therapy ]

    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.


  5. Time to biomarkers (Troponine, pro-BNP, hs-CRP) increase [ Time Frame: Time window of 12 months from the end of radiation therapy ]

    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.


  6. Biomarkers (Troponine, pro-BNP, hs-CRP) predictors of cardiotoxicity [ Time Frame: Time window of 12 months from the end of radiation therapy ]

    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%.


  7. Major cardiovascular events [ Time Frame: follow-up ]
    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

  8. cardiac fibrosis [ Time Frame: through study completion, an average of 1 year ]
    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

  9. acute asymptomatic pericarditis [ Time Frame: through study completion, an average of 1 year ]
    incidence of acute asymptomatic pericarditis after radiation therapy, measured on CMR

  10. cardiac edema [ Time Frame: through study completion, an average of 1 year ]
    investigate if the area of the edema on CRM correlates with RT dose distribution



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed
  2. Age ≥ 18 years at visit 1
  3. Performance status ECOG 0-1
  4. *Stage I-III histology proven breast cancer
  5. Treated with adjuvant radiotherapy and neo/adjuvant anthracycline and/or trastuzumab-based therapy +/- hormonal therapy
  6. 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.

Exclusion Criteria:

  1. Known metastatic spread of any cancer
  2. Known active or recurrent hepatic disorder (cirrhosis, hepatitis), ASAT/ALAT 2xULN
  3. Renal function decrease (eGFR < 30 ml/min)
  4. Known coronary artery disease
  5. Angina pectoris
  6. Positive or missing pregnancy test (pre- and perimenopausal women) at enrolment visit
  7. Patients with baseline LVEF <53% and GLS <15%
  8. Patients with pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790266


Contacts
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Contact: Valli 0041918119430 mariacarla.valli@eoc.ch
Contact: Borgonovo 0041918118926 giulia.borgonovo2@eoc.ch

Locations
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Switzerland
Oncology Institute of Italian Switzerland Recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Mariacarla Valli, MD    0041918119430    mariacarla.valli@eoc.ch   
Contact: Giulia Borgonovo, MD    0041918118926    giulia.borgonovo2@eoc.ch   
Sponsors and Collaborators
Oncology Institute of Southern Switzerland
Cardiocentro Ticino
North Estonia Medical Centre
Fondazione IRCCS Policlinico San Matteo di Pavia
Investigators
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Principal Investigator: mariacarla Valli IOSI
  Study Documents (Full-Text)

Documents provided by Oncology Institute of Southern Switzerland:
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Responsible Party: Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT04790266    
Other Study ID Numbers: 2019-01395CE3508
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries