Clinical trial NCT06282796: Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy
Official title: Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy: a Prospective, Multicenter, Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer Chemotherapy
Anthracyclines
Cardiotoxicity
Early detection
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients with anthracycline-based breast cancer chemotherap

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.

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

Primary outcomes:
measure: Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.
timeFrame: 1 day after admission
Secondary outcomes:
measure: Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy.
timeFrame: 1 day after admission
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Dalian
country: China
facility: Dalian Friendship Hospital
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Chengdu
country: China
facility: The Third People's Hospital Of Chengdu
state: Sichuan
Study officials:
affiliation: the First Hospital of China Medical Univeristy
name: Yonghuai Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: