NCT06282796

Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy

Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy: a Prospective, Multicenter, Clinical Trial

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis.

Detailed description

The latest global cancer burden data released by the World Health Organization International Agency for Research on Cancer (IARC) has shown that the incidence of breast cancer ranks first in the world. Anthracycline-based treatments are first-line chemotherapy agents to treat early breast cancer. Although anthracycline-based treatments has significantly improved the 5-year survival rate of breast cancer patients, the cancer therapy-related cardiac dysfunction (CTRCD) caused by anthracyclines has become the major cause of breast cancer death. However, CTRCD patients often have no obvious symptoms of heart failure in the early stage, and the diagnosis is very secretive, resulting in delayed intervention, unable to timely terminate the disease process, and seriously affecting the prognosis. Echocardiography has the advantages of real-time, non-invasive and repeatable, and is the preferred detection method for asymptomatic CTRCD at present. The diagnosis of asymptomatic CTRCD depends on the change of left ventricular (LV) ejection fraction (EF) and global longitudinal strain (GLS) before and after chemotherapy. However, the measurement of LVEF and GLS is based on manual methods, resulting in poor repeatability. Cardiotoxicity due to anthracycline-based breast cancer chemotherapy progresses gradually and changes dynamically with dose and time. Therefore, this study intends to build an intelligent model for early prediction and warning of asymptomatic CTRCD, so as to provide a reliable basis for timely adjustment of individualized cardiac protection strategies and maintaining LV function and reducing mortality.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Echocardiography	Two-dimensional, color Doppler, spectral Doppler, tissue Doppler and three-dimensional echocardiographic image recordings will be taken using a Philips Epiq 7C echocardiography device and X5-1 probe. Conventional parameters, additional parameters, and strain analyzes will be performed by TomTec AutoStrain Suite Software

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

5 sites across 1 country: China