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临床试验/NCT05673850
NCT05673850已完成不适用

Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy

Peking University1 个研究点 分布在 1 个国家目标入组 518 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
518
试验地点
1
主要终点
pathologic complete response rate (pCR)

研究概览

简要总结

In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. However, the association between HER2-low status with response to endocrine therapy is largely unknown. In this study, we included 518 ER-positive BC patients who received either neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NCT). The pathologic complete response rate (pCR) of HER2-low and HER2-zero tumors re-sponding to neoadjuvant therapies were compared. The difference in disease-free survival (DFS) and overall survival (OS) between the two groups was also analyzed. The pCR (defined as ypT0/isNx) in HER2-low BCs and in HER2-zero BCs for NET cohort and NCT cohort were compared.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021

排除标准

  • 未提供

研究组 & 干预措施

NET

干预措施: NET or NCT (Drug)

NCT

干预措施: NET or NCT (Drug)

结局指标

主要结局

pathologic complete response rate (pCR)

时间窗: through study completion, an average of 6 months

ypT0/isNx

次要结局

未报告次要终点

研究者

发起方
Peking University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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