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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiac Toxicity, Antitumor Drugs, Breast Cancer

Intervention / Treatment
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* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients diagnosed with HER2-positive breast cancer treated in our hospital. 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: Patients who have not been properly treated with trastuzumab or have been treated for less than half a year; Patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment; Patients whose case data were missing or lost to follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Toxicity, Antitumor drugs, Breast Cancer, Trastuzumab