Clinical Application of Circulating Tumor DNA (ctDNA) to Monitor the Molecular Tumor Burden in Patients With Late-stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- ctDNA change index
研究概览
简要总结
This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) application in late-stage breast cancers.
详细描述
This study aims to evaluate the feasibility of plasma ctDNA mutation spectrum and clonal spectrum in late-stage metastatic breast cancer patients. Meanwhile, this study tries to establish a model of ctDNA subtyping system to evaluate the molecular load of tumor, to evaluate the curative effect comprehensively and to detect the disease progression in advance. In addition, the investigators plan to explore the clonal evolution of ctDNA in patients with progressive disease (PD), and to monitor the changes of tumor heterogeneity from the molecular level, so as to provide reference for the analysis of drug sensitivity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
- •No available recommendation for the next treatment regimen;
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- •An updated, available pathological HR/HER2 status for metastasis;
- •According to RECIST 1.1 standard, there should be at least one measurable target lesion;
- •The expected survival time is > 3 months;
- •Those aged 18-70 years old;
- •Liver and kidney function and blood routine test meet the following conditions: Neutrophil > 2.0g/l, Hb > 9g / L, PLT > 100g / L; ALT and AST < 2.5ULN; TBIL < 1.5ULN; Cr < 1.0ULN
- •Signing informed consent;
- •Those willing to accept polygenic testing.
排除标准
- •Patients with multiple primary tumors;
- •Those who are unable to obtain blood samples;
- •Those with a history of immunodeficiency or organ transplantation;
- •Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
- •The researchers think it is not suitable to participate in this experiment.
结局指标
主要结局
ctDNA change index
时间窗: From the date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
The dynamic change of the frequency spectrum of ctDNA mutation in plasma.
次要结局
未报告次要终点