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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282796
• Other study ID #: EPW-CABC-01
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: First Hospital of China Medical University
• Contact: Yonghuai Wang, Ph.D
• Phone: +86 15998323056
• Email: wyh_wyh2012[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age =18 years
• Histologically or cytopathological confirmed stage I-III HER2+ breast cancer, scheduled to receive consecutive anthracycline chemotherapy or subsequent sequential trastuzumab targeted therapy
• LVEF=53% before chemotherapy

Exclusion Criteria:

• life expectancy =12 months
• Participating in other ongoing oncology clinical trials
• Prior treatment with anthracyclines or chest radiation therapy
• Pregnant or lactating women
• Ultrasound images of the heart are of very poor quality

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity

Intervention

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

Locations

Country	Name	City	State
China	The Third People's Hospital Of Chengdu	Chengdu	Sichuan
China	Dalian Friendship Hospital	Dalian	Liaoning
China	Dalian Municipal Central Hospital	Dalian	Liaoning
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.	To Evaluate the changes of cardiac systolic function in all breast cancer patients treated with anthracycline-based chemotherapy.	1 day after admission
Secondary	Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.	To Evaluate of the subclinical changes of cardiac systolic function in all breast cancer patients treated with anthracycline-based chemotherapy.	1 day after admission