To hear about similar clinical trials, please enter your email below
Trial Title:
Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy
NCT ID:
NCT06282796
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cardiotoxicity
Conditions: Keywords:
Breast Cancer Chemotherapy
Anthracyclines
Cardiotoxicity
Early detection
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Echocardiography
Description:
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
Arm group label:
Anthracycline-Based Breast Cancer Chemotherapy Group
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.
Criteria for eligibility:
Study pop:
Breast cancer patients with anthracycline-based breast cancer chemotherap
Sampling method:
Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiqin Huang
Facility:
Name:
Dalian Friendship Hospital
Address:
City:
Dalian
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Zhang
Facility:
Name:
Dalian Municipal Central Hospital
Address:
City:
Dalian
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingxiong Yue
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoxue Zhang
Facility:
Name:
The Third People's Hospital Of Chengdu
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Min Xu
Start date:
January 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
First Hospital of China Medical University
Agency class:
Other
Source:
First Hospital of China Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06282796
