Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for 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
- Disease Control Rate (DCR)
研究概览
简要总结
This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.
详细描述
This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.
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 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.
研究组 & 干预措施
Control group
Control group includes patients without ctDNA abnormality and patients without druggable ctDNA abnormality.
干预措施: Control group (Drug)
Case group
Case group includes patients with druggable ctDNA abnormality.
干预措施: Case group (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.
The total rate of CR+PR+SD after the completion of two cycles of late-line therapy.
Progression-Free Survival
时间窗: From 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 survival time between the beginning of treatment to death or the progression.
次要结局
未报告次要终点