Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Cardiac toxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The case group
Trastuzumab for the treatment of breast cancer patients with cardiotoxicity.
干预措施: Trastuzumab (Drug)
The control group
Trastuzumab is used to treat patients with breast cancer who do not present with cardiotoxicity
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Cardiac toxicity
时间窗: 12 months
Myocardial infarction or other cardiac death
次要结局
未报告次要终点