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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

978 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-01

Study Completion Date

2018-02-28

Brief Summary

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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

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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

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Micrometastases Neoadjuvant Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Joon Jeong

Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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3-2023-0214

Identifier Type: -

Identifier Source: org_study_id