Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer (OMERIC): A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- longitudinal changes in VOCs profile and exosomes according to response to treatment
研究概览
简要总结
This is a monocentric cohort study, prospective and interventional with minimal risks and constraints for advanced breast cancer. The planned interventions are collection of biological samples at different times. The study will aim to do a descriptive analysis of omics profiles evolution (tumor, volatile organic components) over time, before and after disease progression under Palbociclib treatment with a clinical-biological database.
详细描述
Patients enrolled in the study will receive the following interventions:
- Biospecimen sample collection: before and during treatment, and at progression
- Tumor biopsy before treatment and at progression
The aim of this study is to describe molecular changes associated with resistance to Palbociclib at the individual level and describe longitudinal changes in the profile of tumor, VOCs and exosomes according to treatment response.
Other objectives of the study include:
- Proportion of single or shared molecular alterations / signatures between patients at progression time
- Associations between tumor signatures, VOCs and exosomes
- Compare molecular changes identified by proteomics with those observed by genomics / transcriptomics
- Compare the evolution of VOCs and exosomes over time with evolution of liquid biopsy markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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 18 years old
- •With histologically proven breast cancer, positives hormones receptors and negative HER2
- •Advanced disease (metastases or non-resequable locoregional disease), from the 1st to the 4th line.
- •With an indication for hormone therapy associated with the CDK4/6 inhibitor Palbociclib
- •Agree to the sampling of the study
- •Signed the informed consent form
排除标准
- •Neoadjuvant or adjuvant treatment for localized breast cancer
- •Metastatic breast cancer beyond the forth line
- •Impossibility to give informed consent (person deprived of liberty or under guardianship)
结局指标
主要结局
longitudinal changes in VOCs profile and exosomes according to response to treatment
时间窗: From date of inclusion until the date of first documented progression, assessed up to 2 years
variation over time in exosomes count in response to treatment and in progression situations
Intrapatient variation in molecular profiles at progression compared to baseline
时间窗: From date of inclusion until the date of first documented progression (around 2 years)
Variation over time in the rate of VOCs in response to treatment and in progression situations.
次要结局
- Proportion of alterations / molecular signatures unique or shared between patients at progression(At progression time, up to 2 years)
- Correlation between tumor signatures, VOCs and exosomes(At progression time, up to 2 years)