Breast Cancer Clinical Trial
Official title:
Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients
Verified date | January 2021 |
Source | Peking University Third Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 30, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Peking | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac toxicity | The asymptomatic LVEF decreases = 10% of the baseline value or to an absolute value < 50% | 12 months | |
Primary | Cardiac toxicity | acute or chronic heart failure | 12 months | |
Primary | Cardiac toxicity | New or aggravated arrhythmias or coronary heart disease | 12 months | |
Primary | Cardiac toxicity | Myocardial infarction or other cardiac death | 12 months |
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