Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.
试验速览
- 阶段
- 3 期
- 入组人数
- 800
- 试验地点
- 17
- 主要终点
- Economic evaluation
研究概览
简要总结
The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Women with metastatic ductal adenocarcinoma breast cancer
- •18 years old or more
- •Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological analysis available.
- •Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy administration
- •Life expectancy > 3 months
- •Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
- •Information of the patient and signature of the informed consent form
排除标准
- •Patient treated by chemotherapy or hormonotherapy for their metastatic disease (treatment failure under adjuvant hormonotherapy are accepted)
- •Her2 positive breast cancer
- •History of other stage II or III cancer in the 5 years. History of other metastatic cancer (whatever the time between the two cancers).
- •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
Standard
Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.
干预措施: Circulating tumor cells counting at baseline (Biological)
Circulating Tumor Cells
Treatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline :
If <5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy
干预措施: Circulating tumor cells counting at baseline (Biological)
结局指标
主要结局
Economic evaluation
时间窗: 2 years
Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)
Progression free survival evaluation
时间窗: 2 years
According to RECIST 1.1 criteria
次要结局
- Evaluation of treatment safety according to NCI-CTCAEv4.03(2 years)
- Overall survival evaluation(2 years)
- Assessing patient quality of life(2 years)