Borgonovo Giulia, Vettus Elen, Greco Alessandra, Leo Laura Anna, Faletra Francesco Fulvio, Klersy Catherine, Curti Moreno, Valli Mariacarla
Clinic of Radiation Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
Department of Oncology, East Tallinn Central Hospital, Tallinn, Estonia.
JMIR Res Protoc. 2022 Apr 21;11(4):e31887. doi: 10.2196/31887.
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.
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.
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.
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 The results of this study will not be published until data are mature for the final analysis of the primary study end point.
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.
ClinicalTrials.gov NCT04790266; https://clinicaltrials.gov/ct2/show/NCT04790266.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31887.
全球乳腺癌发病率呈上升趋势。全身和局部治疗的最新进展显著提高了早期乳腺癌患者的生存率。在过去十年中，人们高度关注乳腺癌治疗引起的心脏毒性的预防和早期检测。全身治疗相关的心脏毒性已得到广泛研究。放射治疗是乳腺癌治疗的重要组成部分，也会增加患心脏病的风险。因此，平衡癌症治疗的预期益处与心血管风险，并确定预防心脏毒性、改善这些患者长期预后和生活质量的策略非常重要。
这项CardioTox Breast研究旨在研究基于心脏磁共振和超声心动图的心脏成像的应用，并确定相关的循环生物标志物，以评估乳腺癌患者放疗结束后12个月时间窗内化疗和放疗诱导的心脏毒性的早期组织变化。
CardioTox Breast试验是一项多中心观察性前瞻性纵向研究。我们的目标是招募150例接受保乳手术治疗的I-III期单侧乳腺癌女性患者，她们计划接受放疗，无论是否接受全身治疗。基线和随访数据包括基于心脏磁共振成像、超声心动图的心脏测量以及心脏毒性的循环生物标志物。
本研究详细介绍了CardioTox Breast试验的方案。招募工作于2020年9月开始。在主要研究终点的最终分析数据成熟之前，本研究结果不会发表。
CardioTox Breast研究旨在研究全身治疗和放射治疗对心肌功能和结构的影响，从而为心脏磁共振是否是心脏毒性的最佳筛查成像提供更多证据。
ClinicalTrials.gov NCT04790266；https://clinicaltrials.gov/ct2/show/NCT04790266。
国际注册报告识别码（IRRID）：DERR1-10.2196/31887。
