跳至主要内容
临床试验/NCT06583655
NCT06583655进行中(未招募)不适用

A Prospective Study of Individualized Regional Node Irradiation for Sentinel Node-positive Breast Cancer Without Axillary Dissection Based on Clinical and Genomic Risk Assessment

Ruijin Hospital2 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
205
试验地点
2
主要终点
Percentage of patients with arm lymphedema

研究概览

简要总结

Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. Since the publication of IBCSG23-01, ACOSOG Z0011 and AMAROS study, these studies indicated that there was no significant difference in recurrence and overall survival rates between the ALNB and SLNB+ALND followed by adjuvant radiotherapy. Therefore, an adaptation of the strategy to omit axillary lymph node dissection in patients with low-risk axillary involvement who are treated with curative surgery and systematic therapy. However, they also pose new challenges for adjuvant radiotherapy decisions. In the Z0011 study, patients were required to receive breast tangent field radiotherapy. In the AMAROS study, axillary radiotherapy included level I-III axillary lymph node drainage areas and the supraclavicular area, but the study results showed a local recurrence rate of only 1.19% at 5 years in the axillary radiotherapy group. Consequently, there is considerable controversy among clinical experts about whether a combined regional lymphatic drainage area radiotherapy strategy is necessary for low-burden sentinel lymph node metastasis breast cancer patients. In contrast, results from the EORTC-22922 and MA-20 studies, which included patients undergoing axillary lymph node dissection, showed that adjuvant radiotherapy to the entire lymphatic drainage area, including the internal mammary region, reduced the risk of disease-free survival and breast cancer-specific mortality. Therefore, the adjuvant radiotherapy strategy for early breast cancer patients with low-burden sentinel lymph node metastasis remains controversial, with a lack of high-level evidence to support it.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • 1. Histologically confirmed invasive breast cancer;
  • Age between 18 and 80 years;
  • cN0 breast cancer underwent radical surgery combined with Sentinel Lymph Node Dissection (SLND) alone with SLND positive or SLND and axillary lymph node dissection (ALND) with positive lymph node metastasis;
  • for SLND alone cohort, the regional lymph node irradiation area was determined according to the clinical risk model and genomic risk model assessment;
  • Ability to understand and willingness to participate the research and sign the consent form

排除标准

  • • Pathologically positive ipsilateral supraclavicular lymph node
  • Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes;
  • Pregnant or lactating women;
  • Insulin dependent diabetes;
  • History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix;
  • patients have simultaneous contralateral breast cancer;
  • clinical diagnosis of distant metastatic disease;
  • Previous radiotherapy to the neck, chest and/or ipsilateral axillary region

研究组 & 干预措施

Sentinel Lymph Node Dissection alone , clinical low risk group

Experimental

patients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.

Sentinel Lymph Node Dissection alone , clinical high risk but genomic low risk group

Experimental

patients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.

Sentinel Lymph Node Dissection alone ,clinical high risk and genomic high risk group

Experimental

patients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.

with Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)

Active Comparator

patients treated with surgery and Sentinel Lymph Node Dissection and ALND with positive lymph node metastasis.

干预措施: Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND) (Radiation)

结局指标

主要结局

Percentage of patients with arm lymphedema

时间窗: 2 year

Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

次要结局

  • Disease free survival(5 years)
  • Overall survival(5-year)

研究者

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

QIWEIXIANG

Deputy Chief Physician

Ruijin Hospital

研究点 (2)

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