CirCe01 Study: Evaluation of the Use of Circulating Tumour Cells to Guide Chemotherapy From the 3rd Line of Chemotherapy for Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 7
- 主要终点
- Overall Survival
研究概览
简要总结
Evaluation of the use of Circulating tumour Cells to guide chemotherapy from the 3rd line of chemotherapy for metastatic breast cancer.
详细描述
Phase III multicentre, randomized, open-label study comparing early evaluation of the efficacy of chemotherapy by determination of circulating tumour cells versus conventional clinical and radiological evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Women over the age of 18 years.
- •WHO performance status: 0 to
- •Metastatic breast cancer.
- •Progression after 2 lines of chemotherapy with decision to initiate third-line chemotherapy.
- •Disease evaluable by CTC (CTC-positive before starting chemotherapy).
- •Histology: lobular or ductal adenocarcinoma.
- •Information of the patient and signature of the informed consent form by the patient or her legal representative.
排除标准
- •Disease not evaluable by CTC (CTC-negative before starting chemotherapy).
- •History of other potentially metastatic cancer (stage III or IV cancer) different from breast cancer.
- •Histology other than lobular or ductal adenocarcinoma.
- •Pregnant woman, women likely to become pregnant or nursing mothers.
- •Persons deprived of their freedom or under guardianship.
- •Women unable to comply with the medical follow-up of the study for geographical, social or mental reasons.
研究组 & 干预措施
Circulating Tumor Cells
Centralized determination of CTC by CellSearch® technology (Veridex), the only technology currently validated in clinical practice for the early evaluation of response to chemotherapy of breast cancers. This evaluation is performed by blood sampling comparing the CTC level before the first injection of each new line of chemotherapy. Chemotherapy can only be continued in the case of a positive CTC response. Discontinuation of chemotherapy can also be decided by the clinician on the basis of other clinical or radiological arguments.
干预措施: Blood sampling (Biological)
Clinical and radiological criteria
Management of chemotherapy according to the usual clinical and radiological criteria adopted by the patient's attending physician.
干预措施: Usual clinical and radiological criteria (Other)
结局指标
主要结局
Overall Survival
时间窗: 7 years
Overall survival (from date of randomization
次要结局
- Improvement of quality of life(7 years)
- Medico-economical analysis(5 years)
- Time to progression, to discontinuation of therapy after 3rd line.(7 years)
- Measure of safety and tolerability(7 years)
- Estimate the clinical interest, in particular forecast, of the circulating tumoral DNA(3 years)
- Comparison of CTC with usual serum tumour markers(7 years)