Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04961307
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 29.9
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiotoxicity; Antitumor Drugs; Breast Cancer; Trastuzumab	Drug: Trastuzumab

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Heart Function in Breast Cancer Patients Using Trastuzumab
• Actual Study Start Date: Jul 5, 2019
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Women with breast cancer using trastuzumab	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

Outcome Measures

Primary Outcome Measures

1. Time ending [6 months]

   180 days after chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Peking	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04961307
• Other Study ID Numbers: Cardiac safety study
• First Posted: Jul 14, 2021
• Last Update Posted: Jul 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: Cardiac safety; Antitumor drugs; Breast Cancer; Trastuzumab
• Additional relevant MeSH terms: Breast Neoplasms; Cardiotoxicity; Trastuzumab

Study Results

No Results Posted as of Jul 14, 2021