Swiss Oncology Institute started a clinical trial of Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
Oncology Institute of Southern Switzerland is enrolling patients into the clinical trial investigating Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients (CARDIOTOX).
The aim of this study iss 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.
The trial is designed to enroll Female 18 years and older and is being conducted in the Oncology Institute of Italian Switzerland, Bellinzona, Ticino, Switzerland.
The study start date is September 15, 2020.
The population that can be enrolled into this study includes 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.
Patients with the following conditions:
- 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
are excluded from participation.
Cardiocentro Ticino, North Estonia Medical Centre and Policlinico San Matteo Pavia Fondazione IRCCS are the collaborators in this study.
This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04790266
