NCT05910710招募中不适用
Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes)
研究概览
简要总结
It analyzes the Tumor microenvironment(TME) changes in non pathologic complete response(pCR) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer.
(Neoadjuvant Weekly paclitaxel, Carboplatin +- Pembrolizumab followed by Doxorubicin, Cyclophosphamide +- Pembrolizumab regimen)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Triple negative breast cancer
- •Subjects administered neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not
- •Non pCR patients who are undergoing surgery after neoadjuvant chemotherapy
- •Sign to informed consent
排除标准
- •Patients with difficulty in obtaining sufficient samples
结局指标
主要结局
Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes)
时间窗: 3year
Tissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction)
次要结局
未报告次要终点
研究者
Yeon Hee Park
Professor
Samsung Medical Center
研究点 (1)
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