Timing of ctDNA Testing in Advanced Breast Cancer: Impact on Prognosis and Treatment Strategies - A Prospective Observational Study (TIMING)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This multicenter, prospective observational cohort study aims to investigate the impact of circulating tumor DNA (ctDNA) level and key actionable gene mutation status on prognosis and treatment response in patients with advanced breast cancer.
详细描述
This is a non-interventional, real-world observational study. Patients with histologically confirmed advanced breast cancer, aged ≥18 years, with expected survival >3 months, who consent to ctDNA testing will be enrolled. A total of 400 patients will be recruited from multiple centers in China. Peripheral blood (10 mL) will be collected for ctDNA next-generation sequencing panel testing. Results will be returned to clinicians, who decide on subsequent treatment independently. Baseline data, treatment history, treatment regimens, and efficacy assessments (imaging every 8-12 weeks) will be recorded. Follow-up will continue until death or study end. Primary endpoint: overall survival (OS). Secondary endpoints: progression-free survival (PFS), objective response rate (ORR), correlation of ctDNA level/mutations/clonality with treatment response and OS, and correlation of testing timing/clinical decisions with OS. Statistical analysis will use intention-to-treat (ITT) principle, Kaplan-Meier, Cox regression, and subgroup analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced breast cancer
- •Age ≥18 years
- •Expected survival >3 months
- •Willing to undergo ctDNA testing and sign informed consent form
排除标准
- •The subject has not signed the informed consent form.
- •Pregnant or breastfeeding women.
- •Other situations deemed by the investigator as unsuitable for inclusion in the study.
结局指标
主要结局
Overall Survival (OS)
时间窗: From diagnosis until death or study completion, up to 3 years
次要结局
- Progression-Free Survival (PFS)(From enrollment to progression or death, assessed every 8-12 weeks)
- Objective Response Rate (ORR)(From enrollment to end of treatment, assessed every 8-12 weeks)
- Correlation of ctDNA level, gene mutations , clonality with treatment response and OS(From diagnosis to death, up to 3 years)
- Correlation of testing timing (first-line vs. later-line) and clinical decision-making with OS(From diagnosis to death, up to 3 years)
- Objective Response Rate (ORR)(From treatment initiation to end of treatment, assessed every 8-12 weeks)
- Progression-Free Survival (PFS)(From treatment initiation to progression or death, assessed every 8-12 weeks)