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

NCT04790266 | Completed DMC

• 1 other identifier: 2019-01395CE3508
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• 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%).

  Time window of 12 months from the end of radiation therapy

Secondary Outcomes (10)

• GLS

  Time window of 12 months from the end of radiation therapy

• Myocardial edema

  Time window of 12 months from the end of radiation therapy

• Biomarkers (Troponine, pro-BNP, hs-CRP) correlate with LVEF

  Time window of 12 months from the end of radiation therapy

• Biomarkers (Troponine, pro-BNP, hs-CRP) correlated with GLS

  Time window of 12 months from the end of radiation therapy

• Time to biomarkers (Troponine, pro-BNP, hs-CRP) increase

  Time window of 12 months from the end of radiation therapy

Interventions

Cardiac MRI DIAGNOSTIC_TEST

cCardiac MRI, ecocardiography and cardiotoxicity blood tests will be repeated as previously scheduled

Also known as: Echocardiography, Cardiotoxicity laboratory tests (troponin, Pro-BNP, hsCRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead
• Cardiocentro Ticino: collaborator
• North Estonia Medical Centre: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

Oncology Institute of Italian Switzerland

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35451989 DERIVED

MeSH Terms

Conditions

Cardiotoxicity

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• mariacarla Valli

  IOSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 10, 2021
• Study Start: September 15, 2020
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CH (1)