Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

NCT ID: NCT04961307

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-05

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiotoxicity Antitumor Drugs Breast Cancer Trastuzumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with breast cancer using trastuzumab

Trastuzumab

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Weixian T Xu

Role: primary

13810695447

Xin Liu

Role: backup

18801362704

Other Identifiers

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Cardiac safety study

Identifier Type: -

Identifier Source: org_study_id

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