Early Detection of Cardiotoxicity from Systemic and Radiation Therapy in Breast Cancer Patients (CardioTox Breast): Protocol Design of a Multi-Institutional Prospective Study (Preprint)

Abstract

Incidence of breast cancer is rising worldwide. Recent advances in systemic and local treatments have significantly improved survival rates of early breast cancer patients. In the last decade, great attention has been paid to prevention and early detection of cardiotoxicity induced by breast cancer treatments. Systemic therapy-related cardiac toxicities have been extensively studied. Radiotherapy, an essential component of breast cancer treatment, can also increase the risk of heart diseases. Consequently, it is important to balance the expected benefits of cancer treatment with cardiovascular risk and to identify strategies to prevent cardiotoxicity and improve long-term outcomes and quality of life for these patients.

The CardioTox Breast study aims to investigate the use of cardiac imaging, based on cardiac magnetic resonance and echocardiography, and to identify associated circulating biomarkers to assess early tissue changes in chemo- and radiation-induced cardiotoxicity in the time window of 12 months after the end of radiotherapy in breast cancer patients.

The CardioTox Breast trial is a multicenter, observational prospective longitudinal study. We plan to enrol 150 women with stage I-III, unilateral, breast cancer treated with breast conserving surgery and planned to receive radiotherapy with or without systemic therapy. Baseline and follow-up data include cardiac measurements based on cardiac magnetic resonance imaging, echocardiography, and circulating biomarkers of cardiac toxicity.

This study details the protocol of the CardioTox Breast trial. Recruitment started in September 2020. Results of the present study will not be published until data are mature for the final analysis of the primary study endpoint.

The CardioTox Breast study is designed to investigate the effects of systemic and radiation therapy on myocardial function and structure, thus providing additional evidence on whether CMR is the optimal screening imaging for cardiotoxicity.

ClinicalTrials.gov Identifier: NCT04790266