Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- predictive molecular abnormalities assessment
研究概览
简要总结
Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
详细描述
Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •proven invasive breast adenocarcinoma (cytology and / or biopsy).
- •locally advanced stage (tumor size greater than 2 cm).
- •neoadjuvant chemotherapy indication validated RCP
- •Patient eligible for neoadjuvant chemotherapy.
- •Performance Index according to WHO or less
- •Patient aged 18 years and older.
- •Being affiliated to a social security scheme or an equivalent scheme of social protection
- •Obtaining signed informed consent, and that before any specific prequalification testing.
排除标准
- •presence of metastatic disease at diagnosis.
- •Breast Cancer inflammatory.
- •rare histologic subtypes (non ductal lobular and not).
- •Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years.
- •Patient pregnant or nursing or of childbearing age without effective contraception.
- •Breast cancer in men.
- •legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L1211-9).
研究组 & 干预措施
Blood sample
Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).
干预措施: Blood sample (Biological)
结局指标
主要结局
predictive molecular abnormalities assessment
时间窗: up to 5 years
Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
次要结局
未报告次要终点