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NCT Number: NCT06282796

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Fujian Cancer Hospital, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Device

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

Primary outcomes

  1. Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.

    Time frame: 1 day after admission

    To Evaluate the changes of cardiac systolic function in all breast cancer patients treated with anthracycline-based chemotherapy.

Secondary outcomes

  1. Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.

    Time frame: 1 day after admission

    To Evaluate of the subclinical changes of cardiac systolic function in all breast cancer patients treated with anthracycline-based chemotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Yonghuai Wang, Ph.D

CONTACT

[email protected]

+86 15998323056

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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