跳至主要内容
临床试验/NCT03273426
NCT03273426已完成不适用

Prediction of Pathologic Complete Response by Multiple Core Needle Biopsy or Vacuum Assisted Biopsy Before Surgery in Breast Cancer With Complete Clinical Response After Neoadjuvant Chemotherapy.

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Negative Predictive Value

研究概览

简要总结

The purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.

详细描述

Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). The patient will undergo subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the surgical specimen will be compared for pCR, and the ability of preoperative biopsies to predict pCR will be evaluated.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)
  • who received NAC
  • with detectable lesion / clip marker on ultrasound
  • with cT1-T3 tumors
  • clinical and imaging complete or near-complete response on MRI
  • with informed consent

排除标准

  • Multifocal cancer
  • Residual microcalcification
  • Contralateral breast cancer

结局指标

主要结局

Negative Predictive Value

时间窗: 2 weeks

Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR

次要结局

  • False Negative Rate(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wonshik Han

Professor

Seoul National University Hospital

研究点 (2)

Loading locations...

相似试验