Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHenan Cancer Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • SLNB group

    Other intervention

    After 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

508 Participants
are divided into 1 treatment group
Group A: SLNB group1 intervention

Trial outcomes

Primary outcomes

1

Axillary recurrence-free survival

The time from surgery to axillary recurrence or last follow-up

Time frame
5th year after surgery

Secondary outcomes

1

regional lymph node recurrence-free survival

The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up

Time frame
5th year after surgery
2

Disease-free survival

The time from surgery to the occurrence of recurrence, metastasis, or last follow-up

Time frame
5th year after surgery
3

Overall survival

The time from surgery to patient death or last follow-up

Time frame
5th year after surgery
4

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.

Time frame
5th year after surgery

Other outcomes

Sponsors and contacts

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