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.
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
- 否
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
Wonshik Han
Professor
Seoul National University Hospital
