NCT05360290招募中不适用
The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 484
- 试验地点
- 2
- 主要终点
- invasive disease-free survival (iDFS)
研究概览
简要总结
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide, which is CE approved. This is a prospective, multicenter study to evaluate the prognostic value of circulating tumor cells in breast cancer patients who completed surgery after neoadjuvant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Female, aged ≥18 and ≤70 years;
- •Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment);
- •Completed neoadjuvant treamtment and surgery (within 4 years after surgery);
- •Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen);
排除标准
- •Metastatic disease (Stage IV);
- •Female patients who are pregnancy or lactation;
- •Uncontrollable puncture site infection or systemic infection;
研究组 & 干预措施
CTC positive
Active Comparator
干预措施: GILUPI CellCollector® (Device)
CTC negative
Other
干预措施: GILUPI CellCollector® (Device)
结局指标
主要结局
invasive disease-free survival (iDFS)
时间窗: From surgery until time of event up to 3 years
Invasive disease-free survival time is defined as the time from date of randomization until the first occurrence of invasive disease recurrence, distant metastasis and death from any cause.
次要结局
- overall Survival (OS)(From surgery until time of event up to 3 years)
- pathological complete response (pCR)(at surgery)
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital
研究点 (2)
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