NCT02854618Unknown不适用
Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- level of the spontaneous anti-telomerase response
研究概览
简要总结
This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients eligible for a treatment by everolimus in association with the exemestane
- •Performance status of 0,1 or 2 according to the WHO
- •Patients affected of a breast cancer advanced and\or metastatic HER2 negative expressing the hormonal receptor RH +
- •menopausal Patients
排除标准
- •Psychiatric disease compromising the understanding of the information or the realization of the study
- •Vulnerable people according to the law (minors, adults under protection, private persons of freedom)
- •Histories of cancer in 5 years preceding the diagnosis (except breast cancer, squamous-cell)
- •Not menopausal women
- •Unaffiliated people to the Social Security
- •People being for the period of exclusion from another study
- •Hypersensitivity in the active substance, in the other by-products of the rapamycin or in one of the excipients.
- •Symptomatic visceral achievement
- •Legal incapacity or limited legal capacity
结局指标
主要结局
level of the spontaneous anti-telomerase response
时间窗: 12 months
evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test)
次要结局
- T lymphocytes level(12 months)
- everolimus level in serum patients(12 months)
- angiopoietin 2 level(12 months)
- CD138 level(12 months)
- ps6K expression(12 months)
- Merlin expression(12 months)
- neuropilin 2 expression(12 months)
- quality of life(12 months)
研究者
研究点 (2)
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