About this trial
SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients With ECOG Score 0-1 Points
Patients With Breast Cancer Stage cT1-3N1M0 (According to AJCC Version 7) Pathological Diagnosis of Ipsilateral Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer
Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
Patients With Effective Neoadjuvant Therapy (CR+PR)
Disqualifiers
Stage IV (metastatic) breast cancer;
Simultaneous double breast cancer;
Baseline cT4;
Baseline cN2-3
Trial population
Breast cancer patients with positive initial cT1-3N1 axillary lymph nodes
Trial design
Case-only
Prospective
Treatments tested in this trial
SLNB group
Other interventionAfter the completion of neoadjuvant therapy, axillary SLNB should be performed first before breast surgery; If the frozen pathology SLNs are negative, ALND will no longer be performed; If frozen pathological SLNs are positive, ALND should be performed directly; If frozen pathology is false negative.
Treatment groups
Trial outcomes
Primary outcomes
Axillary recurrence-free survival
The time from surgery to axillary recurrence or last follow-up
Secondary outcomes
regional lymph node recurrence-free survival
The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up
Disease-free survival
The time from surgery to the occurrence of recurrence, metastasis, or last follow-up
Overall survival
The time from surgery to patient death or last follow-up
The incidence of postoperative upper limb lymphedema
By using the circumference method, the styloid process of the ulna is taken as the starting point, with an interval of 10cm and measured up to 40cm. The circumference is measured, and the volume of the affected limb is ≥ 10% or\>200ml.
Sponsors and contacts
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