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SLND(clinical low risk) / Breast Cancer Invasive / SLND alone ,clinical high risk and genomic high risk group · Interventional Study
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an ongoing interventional study comparing radiotherapy strategies (sentinel lymph node dissection alone versus combined with axillary dissection, stratified by clinical and genomic risk) in sentinel node-positive breast cancer. The primary endpoint is arm lymphedema at 2 years. No results are yet reported in this registry record.
Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Breast Cancer Invasive; Female; age from 18 Years; to 80 Years. Intervention: Sentinel Lymph Node Dissection alone , clinical low risk gr…; Sentinel Lymph Node Dissection alone , clinical high risk b…; Sentinel Lymph Node Dissection alone ,clinical high risk an…. Compared with: with Sentinel Lymph Node Dissection(SLND) + axillary lymph… — Active Comparator. n = 205. 1 site: China.
This is an ongoing interventional study comparing radiotherapy strategies (sentinel lymph node dissection alone versus combined with axillary dissection, stratified by clinical and genomic risk) in sentinel node-positive breast cancer. The primary endpoint is arm lymphedema at 2 years. No results are yet reported in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Once results are reported, this study will directly inform whether omission of axillary lymph node dissection in low-risk sentinel node-positive patients, combined with selective radiotherapy, reduces lymphedema risk compared to standard axillary dissection. Results may help resolve current controversy about optimal adjuvant radiotherapy strategy in this population.
This is a prospective registry record of an active interventional study with no reported results; it describes a planned comparison of radiotherapy strategies in sentinel node-positive breast cancer but carries no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Once results are reported, this study will directly inform whether omission of axillary lymph node dissection in low-risk sentinel node-positive patients, combined with selective radiotherapy, reduces lymphedema risk compared to standard axillary dissection. Results may help resolve current controversy about optimal adjuvant radiotherapy strategy in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06583655). This is a study registration, not published results. Lead sponsor: Ruijin Hospital. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 205 participants (ESTIMATED). Conditions: Breast Cancer Invasive. Interventions: RADIATION: SLND(clinical low risk); RADIATION: SLND(clinical high risk, genomic low risk); RADIATION: SLND alone ,clinical high risk and genomic high risk group; RADIATION: Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND). Primary outcome measures: Percentage of patients with arm lymphedema , 2 year. Brief summary: 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.
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