NCT02536625已完成不适用
RAPANK: Study of the Impact of Everolimus Treatment on the Development and Functions of Lymphocytes NK (Natural Killer), for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Measure of the level of Granzyme B (GzmB)
研究概览
简要总结
NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 > 18 years old
- •Metastatic breast cancer HR+ (Hormone Receptor positive), HER2/neu negative (Human Epidermal Growth Factor Receptor-2)
- •ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤2
- •Eligible to an hormonotherapy treatment combined to an mTOR (mammalian Target Of Rapamycin) inhibitor (i.e. SPC (Summary of Product Characteristics) modalities)
- •Measurable disease according to RECIST 1.1 (Response Evaluation Criteria In Solid Tumors)
- •Not receiving the non-authorized concomitant treatments
- •Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
- •Patients must be covered by a medical insurance
排除标准
- •All dysimmune disease, history of transplantation or immunosuppressive therapy or corticotherapy
- •All chronic inflammatory diseases
- •Last chemotherapy < 6 months
- •Corticotherapy <1 year and more than 1 month
- •Restrictive diet ≤3 months before inclusion
结局指标
主要结局
Measure of the level of Granzyme B (GzmB)
时间窗: Timepoint at 3 months
次要结局
- mTOR activation status(Timepoint at 3 months and at 9 months)
- Objective Response Rate(12 months)
- Progression-Free Survival (PFS)(12 months)
- Overall Survival (OS)(12 months)
- Intercurrent diseases reporting(12 months)
- Circulating NK functions(Timepoint at 3 months and at 9 months)
研究者
研究点 (2)
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