Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

NCT04961307 | Unknown DMC

• 1 other identifier: Cardiac safety study
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiotoxicity; Antitumor Drugs; Breast Cancer; Trastuzumab

Keywords

Cardiac safety; Antitumor drugs; Breast Cancer; Trastuzumab

Outcome Measures

Primary Outcomes (1)

• Time ending

  180 days after chemotherapy

  6 months

Study Arms (1)

Women with breast cancer using trastuzumab

Drug: Trastuzumab

Interventions

Trastuzumab 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

Women with breast cancer using trastuzumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• Patients with breast cancer (18-70 years old)
• Patients who are planning to undergo trastuzumab for the first time

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 14, 2021
• Study Start: July 5, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-06

Locations

CN (1)