Key result
The CardioTox Breast trial protocol outlines a prospective observational study to evaluate cardiac imaging and biomarkers for early detection of cardiotoxicity in 150 women with breast cancer undergoing radiotherapy.
Why the study?
Balancing breast cancer treatment benefits with cardiovascular risk requires strategies to detect chemo-induced and radiation-induced cardiotoxicity early and assess whether cardiac magnetic resonance is optimal for screening.
Observational (n=150)
Yes
This study protocol outlines a prospective multicenter trial to evaluate whether cardiac magnetic resonance, echocardiography, and circulating biomarkers can detect early subclinical cardiotoxicity in breast cancer patients undergoing radiation and systemic therapy.
May guide cardiotoxicity surveillance development in breast cancer radiotherapy; leaves open validation of CMR, echo, and biomarkers.
BACKGROUND: The incidence of breast cancer is rising worldwide. Recent advances in systemic and local treatments have significantly improved survival rates of patients having early breast cancer. In the last decade, great attention has been paid to the 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. OBJECTIVE: This 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-induced and radiation-induced cardiotoxicity in the time window of 12 months after the end of radiotherapy in patients with breast cancer. METHODS: The CardioTox Breast trial is a multicenter observational prospective longitudinal study. We aim to enroll 150 women with stage I-III unilateral breast cancer, treated with breast conserving surgery, who 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. RESULTS: This study details the protocol of the CardioTox Breast trial. Recruitment started in September 2020. The results of this study will not be published until data are mature for the final analysis of the primary study end point. CONCLUSIONS: 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 cardiac magnetic resonance is the optimal screening imaging for cardiotoxicity. TRIAL REGISTRATION: ClinicalTrials.gov NCT04790266; https://clinicaltrials.gov/ct2/show/NCT04790266. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31887.
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Borgonovo et al. (2021) conducted an observational in Breast cancer (n=150). Radiation therapy with or without systemic therapy was evaluated on Incidence of cardiotoxicity (decline of LVEF ≥10% points with a final LVEF of <53%) measured on CMR and ECHO over 12 months from the end of radiation therapy. The CardioTox Breast trial protocol outlines a prospective observational study to evaluate cardiac imaging and biomarkers for early detection of cardiotoxicity in 150 women with breast cancer undergoing radiotherapy.
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