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临床试验/NCT03715686
NCT03715686Unknown不适用

To Accurately Assess Lymph Node Response to Neoadjuvant Chemotherapy by Wire Localization of Clip-marked Axillary Lymph Nodes in Breast Cancer Patients

Peking University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2018年10月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
230
试验地点
1
主要终点
The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.

研究概览

简要总结

The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in clinical stage N1 (cN1) breast cancer patients. Accuracy of sentinel lymph node biopsy (SLNB) alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. New model to predict lymph node pathological complete remission (pCR) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients is sought for.

详细描述

The investigator developed this protocol to accurately assess lymph node response to neoadjuvant chemotherapy in cN1 breast cancer patients. In brief, pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy (NACT) and continuously monitored through out the course of chemotherapy with ultrasound. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. Axillary lymph node dissection (ALND) will be performed in all participants. Accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes will be analyzed. Axillary ultrasound and CT scan will be performed before and after neoadjuvant chemotherapy for all patients enrolled. By assessing clinical-pathological and imaging data acquired from this trial, the investigator look forward to developing a model to accurately predict lymph node pCR (AUC >0.85) so as to safely avoid axillary lymph node dissection in cN1 breast cancer patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • between the age of 18 and 65
  • Eastern Cooperative Oncology Group (ECOG) score 0 or 1
  • pathologically proven positive axillary lymph node
  • enough renal and liver function to sustain chemotherapy
  • informed consent obtained

排除标准

  • inflammatory breast cancer
  • being pregnant or nursing
  • neoadjuvant chemotherapy not planned

结局指标

主要结局

The accuracy of SLNB alone and in combination with the removal of wire-localized-clip-marked nodes.

时间窗: through study completion, an average of 1 year

Sensitivity, specificity, false negative rate and negative predictive value will be calculated.

次要结局

  • Model to predict lymph node pCR in cN1 patients.(through study completion, an average of 1 year)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tao OUYANG

director of the department

Peking University Cancer Hospital & Institute

研究点 (1)

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