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临床试验/NCT02031042
NCT02031042已完成不适用

Sentinel Node Biopsy Before and/or After Neoadjuvant Chemotherapy in Breast Cancer

Stockholm South General Hospital20 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
224
试验地点
20
主要终点
False negative rate

研究概览

简要总结

The purpose of this study is to investigate if sentinel lymph node biopsy is a reliable staging tool for breast cancer patients planned for neoadjuvant chemotherapy (=before breast surgery) and if, in that case, it is safe to omit axillary lymph node dissection if the sentinel lymph node is free of metastasis.

详细描述

Sentinel lymph node biopsy (SLNB) was introduced in the late 1990´s and has become standard procedure for staging of the axilla in early stage breast cancer associated with significantly less arm morbidity than axillary lymph node dissection (ALND).

Neoadjuvant chemotherapy (NAC) given before breast surgery is indicated for locally advanced breast cancer but is increasingly used for early stage breast cancer with the purpose of downstaging the tumor and thereby possibly enabling breast conserving surgery. Traditionally, the standard axillary staging tool has been ALND although up to 50 per cent of the patients at diagnosis do not have any metastases in their axillary lymph nodes. In addition, NAC can eradicate metastases in the axillary lymph nodes in up to 40 per cent of the patients.

SLNB has therefore been evaluated in the neoadjuvant setting both before and after NAC but is still controversial and the timing debated.

This is a Swedish prospective multi-institutional study without any comparison goup. The comparison is between the findings in the SLNB and the following ALND performed after NAC in all patients.

If the patient is clinically node-negative at diagnosis a SLNB is performed before (without frozen section) and after NAC (substudy I). The reasons for repeating SLNB both before and after NAC are 1) to find out what happens during NAC 2) if it is possible to identify a repeat SLNB and 3) if it is reliable.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • clinically node-negative (or unclear nodal status) substudy I
  • signed consent from the study participant

排除标准

  • inflammatory breast cancer
  • cytologically verified lymph node metastasis/es at diagnosis (substudy I), but these patients can be included in substudy II
  • patients not able to give an informed consent
  • hypersensitivity or allergy against blue dye or isotope

结局指标

主要结局

False negative rate

时间窗: Up to two years

The rate of patients with no metastasis/ses in their sentinel lymph node/s before neoadjuvant chemotherapy (NAC) but metastasis/ses in the nodes from the axillary lymph node dissection performed after NAC will be analysed. In substudy II we also investigate the false negative rate in sentinel lymph node biopsies performed after NAC if the patient had positive lymph nodes at diagnosis.

次要结局

  • Identification rate(Up to two years)

研究者

发起方
Stockholm South General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Zetterlund

MD, PhD student

Stockholm South General Hospital

研究点 (20)

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