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NCT04961307 Clinical Trial

Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

Breast Cancer Clinical Trial

Official title:
Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04961307
Other study ID # Cardiac safety study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 5, 2019
Est. completion date December 30, 2021

Study information
Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

By dynamically observing the changes of echocardiogram and biomarkers in breast cancer patients using trastuzumab, evaluate the effect of trastuzumab on cardiac function; determine the sensitivity of echocardiography and biomarker indicators And specificity, explore effective and specific early warning indicators, and provide technical support for the evaluation of the cardiac safety of anti-tumor drugs.

Description:

Thirty female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase), follow-up echocardiography and biomarkers at 1 month, 3 months and 6 months after chemotherapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 30, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients with breast cancer (18-70 years old) - Patients who are planning to undergo trastuzumab for the first time Exclusion Criteria: - Organic heart disease such as coronary heart disease, heart valve disease, cardiomyopathy - liver and kidney failure - severe cerebrovascular disease - chronic obstructive pulmonary disease - rheumatic immune system disease - other tumors

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Trastuzumab
30 female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase

Locations
Country Name City State
China Peking University Third Hospital Peking Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time ending 180 days after chemotherapy 6 months
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