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临床试验/NCT04741737
NCT04741737招募中不适用

Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence Without Distant Metastasis: A Single-arm, Multicenter, Prospective Study

Gangnam Severance Hospital2 个研究点 分布在 1 个国家目标入组 532 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
532
试验地点
2
主要终点
5 year disease free survival

研究概览

简要总结

According to the standard treatment guidelines established until recently, in the case of ipsilateral breast tumor recurrence without systemic metastasis, salvage mastectomy or lumpectomy can be performed when either partial or whole breast radiation therapy is possible. On the other hand, there are currently no standard treatment guidelines for axillary treatment, and the evidence for this is limited. Axillary lymph node metastasis was reported to occur in about 26% of breast cancer patients who had negative sentinel lymph nodes from previous surgery for primary breast cancer and only local recurrence occurred. It is still important in the decision of treatment or adjuvant radiation therapy. However, it is known that most of the patients with ipsilateral breast recurrence do not have axillary lymph node metastasis. Therefore, performing axillary axillary surgery in all of these patients does not help the patient's survival in many cases, but rather can lead to complications such as lymphedema and seroma and postoperative wound infection. A question about the implementation of axillary lymph node resection has been raised and for this reason, it is necessary to study whether surveillance lymph node biopsy is still effective in patients with recurrence in the ipsilateral breast.

Most of the studies on ipsilateral breast tumor recurrence without systemic metastasis reported to date are case reports or small retrospective studies. In addition, the combined meta-analysis also has limitations in that the study design is not uniform, and there are many cases in which primary breast cancer surgery performed total mastectomy or axillary lymph node dissection. This study is a multicenter prospective study designed to validate the clinical effectiveness of repeat-SLNB conducted in patients with ipsilateral breast tumor recurrence among patients who previously underwent breast conservation and sentinel lymph node biopsy for unilateral primary breast cancer.

研究设计

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

入排标准

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

入选标准

  • Age over 19 years old
  • Patients who are expected to undergo surgery under the diagnosis of ipsilateral breast tumor recurrence(histologically confirmed in situ disease or invasive disease)
  • Patients who had partial mastectomy and sentinel lymph node biopsy for prior operation for the initially diagnosed breast cancer
  • Patients considered to be axillary lymph node negative from clinical findings
  • Patients who understand and willingly participate in the study

排除标准

  • Patients with recurrence in other regions. (e.g. ipsilateral axillary lymph node, supraclavicular lymph node, internal mammary lymph node, etc.)
  • Patients who are not eligible to perform SLNB
  • Patients who received mastectomy or axillary lymph node dissection for prior operation
  • Patients who experienced recurrence within a year from the primary operation
  • Patientes who are known to have axillary lymph node metastasis before the secondary operation, histologically confirmed from tissue biopsy or cytology
  • Patients with systemic recurrence
  • Patients with inflammatory breast cancer
  • Pregnant and lactating patients

结局指标

主要结局

5 year disease free survival

时间窗: 5 years after surgery (re-SLNB)

To prove non-inferiority of re-SLNB compared to ALND regarding disease free survival

次要结局

  • 5-year overall survival(5 years after surgery)
  • survival by tumor subtype(5 years after surgery)
  • 5-year distant metastasis free survival(5 years after surgery)
  • 5-year regional recurrence free survival(5 years after surgery)
  • 5-year DFS by tumor location(5 years after surgery)
  • 5-year local recurrence free survival(5 years after surgery)
  • survival by adjuvant treatment(5 years after surgery)
  • identification rate of sentinel lymph node(5 years after surgery)
  • identification rate of sentinel lymph node by tumor location(5 years after surgery)

研究者

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

Joon Jeong

Professor

Gangnam Severance Hospital

研究点 (2)

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