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临床试验/NCT04986306
NCT04986306Unknown不适用

The Validation of Sentinel Lymph Node Biopsy After Neo-adjuvant Chemotherapy in Breast Cancer Patients in National Cheng Kung University Hospital (NCKUH)

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
The impact of clipped lymph node in patients who received SLNB and ALND following neoadjuvant chemotherapy

研究概览

简要总结

Neoadjuvant or primary systemic treatment is increasingly applied in the treatment of operable breast cancer. Down staging of the primary tumor is one of the important goals of neoadjuvant chemotherapy treatment (NCT), thereby permitting breast-conserving treatment without affecting the risk for a local relapse. Complete pathological response (pCR) rates after NCT vary across histological subtypes and can be more than 60% in HER2-positive disease with dual blockade therapy. Down staging of the axilla is also observed in patients initially presenting with metastatic lymph nodes. pCR rates in the axilla vary between 22% and 42% in reported series, again depending on tumor subtype. Omission of axillary lymph node dissection (ALND) can avoid the post-operative morbidity such as lymphedema in the short or long term follow-up.

Metastatic lymph node status is hard to be stated as a pCR in the axilla by using physical examination or imaging such as ultrasonography or tomography after complete NCT. Good response to the axilla lymph node causing the difficulty of tissue proof by using core needle biopsy, though the investigator knew that biopsy stands for the definite tool for the confirmation of the residual disease. One proposed method to decrease the false-negative rate (FNR) is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery.

The correlation between the axillary lymph node identified on initial axillary ultrasound and the sentinel lymph nodes (SLNs) identified at surgery has not been fully evaluated. The concordance between percutaneous biopsy and the lymph node resected at the time of SLNB is not 100%. Sometimes, the initial node identified by ultrasound is not one of the SLNs. The impairment of the performance of SLNB might correlated to the alteration of lymphatic flow induced by tissue fibrosis or tumor deposits after NCT.

The investigator hypothesized that the clip placement at diagnosis of node-positive disease with removal of the clipped node during SLNB reduces the FNR of SLNB after NCT. Here, we evaluate how often the lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs, and how often it was found in the nodes retrieved at ALND. In addition, the investigator report the impact of identification of the clipped node within the SLNs on the FNR of SLNB.

详细描述

Aim 1: Identify the pathological result of SLN and ALN

Hypothesis:

The lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs

Method:

This study is a prospective study. 30 patients who will undergo neoadjuvant chemotherapy were asked to participate in this study. Informed consent will be given. Clip will be placed over the positive lymph node by surgeon which was proven by fine-needle aspiration cytology. After completion of neoadjuvant chemotherapy, surgery of the breast and the axilla was executed in the same session. Different surgeons performed the procedure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥ 20 years.
  • Primary breast cancer, not metastasis from other cancer.
  • Histological subtypes: invasive ductal carcinoma.
  • Clinical stage: cT1-3, cN1, cM
  • Clip localization over at least one axillary lymph node.
  • After neoadjuvant chemotherapy (NCT). The inclusion criteria and regimens of NCT are followed standard guildline of National Cheng Kung University Hospital.
  • Complete response or partial response after NCT.
  • Written inform consent.

排除标准

  • Refuse to join the study.
  • Unable to complete standard regimens of NCT.
  • Metastasis in internal mammary nodes or other distant lymph nodes.
  • Pregnancy

结局指标

主要结局

The impact of clipped lymph node in patients who received SLNB and ALND following neoadjuvant chemotherapy

时间窗: immediately after the surgery

compare the location of clipped lymph node in SLNB or ALND

次要结局

  • Correlation of the pathologic response observed in the clipped node and SLNB(immediately after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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