Micrometastases in Axillary Lymph Nodes in Breast Cancer, Post-neoadjuvant Chemotherapy

NCT06149884 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 978

Last updated 2023-11-29

No results posted yet for this study

Summary

This study aims to investigate the significance of minimal residual axillary disease following NAC, with a particular focus on micrometastases (ypNmi), in comparison to pathologic lymph node-negative (ypN0) or macrometastases (ypN+). The investigators will further explore the prognostic implications of SLNmi for the prediction of axillary LN status and survival outcomes.

Conditions

  • Micrometastases
  • Neoadjuvant Chemotherapy

Interventions

PROCEDURE

Sentinel lymph node biopsy, axillary lymph node dissection

SLNB was performed using single or dual tracers. For the single tracer technique, Technetium 99, a radioactive substance, was administered periareolarly prior to surgery, and SLNs were identified intraoperatively via a gamma detection system (Neoprobe®). The dual tracer method employed both an isosulfan blue dye and Technetium 99 concurrently. The choice of SLNB technique was contingent upon the surgeon's discretion. SLNs were categorized as one or multiple, and any LN identified by either or both methods was defined as SLN. LNs resected during SLNB without tracer signal were not classified as SLNs. ALND was characterized by the removal of all LNs in axillary levels I and II. Patients documented to have undergone ALND in surgical records were primarily selected from our registry. Among them, those with fewer than 10 LNs were excluded, based on the assumption that a competent ALND necessitated the removal of 10 or more LNs as defined in previous studies

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-01
Primary Completion
2018-02-28
Completion
2018-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06149884 on ClinicalTrials.gov