Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients

July 4, 2021 updated by: Peking University Third Hospital
According to the existing clinical data in our hospital, retrospective study was conducted to screen the risk factors with predictive value for TRC(trastuzumab-related cardiotoxicity) risk, and to construct the risk prediction model for TRC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The breast cancer patients with cardiotoxicity caused by trastuzumab were selected as the case group, and the breast cancer patients without cardiotoxicity were selected as the control group. The clinical baseline data, echocardiographic parameters and serum markers of the case group and the control group were compared to find out the risk factors that may have predictive value for the risk of TRC. The target factors were analyzed by univariate analysis and multivariate Logistic regression analysis, and the TRC risk prediction model was established.

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All subjects were women aged >18 years, diagnosed with HER2-positive breast cancer and already receiving trastuzumab treatment.

Description

Inclusion Criteria:

  1. Female patients diagnosed with HER2-positive breast cancer treated in our hospital.
  2. Surgical treatment combined with chemotherapy or radiotherapy was completed according to NCCN guidelines, and trastuzumab standard treatment was received for at least half a year.

(3) Cardiac function (including echocardiography or biomarkers) was assessed at least once within 3 months before trastuzumab treatment, and at least once during or after treatment was performed for heart-related tests.

(4) Complete case data.

Exclusion Criteria:

  1. Patients who have not been properly treated with trastuzumab or have been treated for less than half a year;
  2. Patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment;
  3. Patients whose case data were missing or lost to follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The case group
Trastuzumab for the treatment of breast cancer patients with cardiotoxicity.
Drug: Trastuzumab
Trastuzumab [Herceptin] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells.
The control group
Trastuzumab is used to treat patients with breast cancer who do not present with cardiotoxicity
Drug: Trastuzumab
Trastuzumab [Herceptin] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac toxicity
Time Frame: 12 months
The asymptomatic LVEF decreases ≥ 10% of the baseline value or to an absolute value < 50%
12 months
Cardiac toxicity
Time Frame: 12 months
acute or chronic heart failure
12 months
Cardiac toxicity
Time Frame: 12 months
New or aggravated arrhythmias or coronary heart disease
12 months
Cardiac toxicity
Time Frame: 12 months
Myocardial infarction or other cardiac death
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiotoxicity study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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