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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06149884
Enrollment
978
Registered
2023-11-29
Start date
2006-09-01
Completion date
2018-02-28
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Micrometastases, Neoadjuvant Chemotherapy

Brief 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.

Detailed description

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.

Interventions

PROCEDURESentinel 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

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Stage II or III primary breast cancer patients * Patients who performed neoadjuvant chemotherpay * Patients who underwent axillary lymph node dissection with or without sentinel lymph node biopsy

Exclusion criteria

* Patients who performed upfront surgery * De novo stage IV patients

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-free survivalthe interval from breast cancer diagnosis to the initial recurrence or death upto 5 yearslocoregional recurrence, distant metastasis, any cause of death

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026