Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy: a Prospective, Multicenter, Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- First Hospital of China Medical University
- Enrollment
- 600
- Locations
- 5
- Primary Endpoint
- Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Chunyan Ma
Chief of Cardiovascular Ultrasound
First Hospital of China Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.(1 day after admission)