Recruiting

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

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…

ClinicalTrials.gov IDNCT06518135

PhaseNot Applicable

Enrollment508

SponsorHenan Cancer Hospital

Age18 Years – 70 Years

SexALL

I'm interested View official listing

Conditions studied

Sentinel Lymph Node Biopsy

About this study

Interventions

Other: SLNB group — 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.

Primary outcomes

Axillary recurrence-free survival (5th year after surgery)

Eligibility information

Inclusion Criteria: 1. Patients With ECOG Score 0-1 Points 2. 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 3. Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination 4. Patients With Effective Neoadjuvant Therapy (CR+PR) 5. Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy 6. Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy 7. Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ) 8. Patients Without Obvious Contraindications for Surgery or Radiation Therapy 9. No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study 10. Patients Who Participate in Other Clinical Trials at the Same Time and Are Judged by the Researchers Not to Affect the Study Protocol Can be Enrolled Normally 11. The patient voluntarily joined this study and signed an informed consent form. Exclusion Criteria: 1. Stage IV (metastatic) breast cancer； 2. Simultaneous double breast cancer； 3. Baseline cT4; 4. Baseline cN2-3 5. gestation 6. There are contraindications for SLNB; 7. Suffering from serious comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study

Study locations

Henan cacer hospital, Henan, Henan 450008 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.