Micrometastases in Axillary Lymph Nodes… | Clinical Trial

Key information

Conditions

Micrometastases Neoadjuvant Chemotherapy Neoplasm Metastasis Neoplasm Micrometastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel lymph node biopsy, axillary lymph node dissection

Procedure

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

Primary outcomes

Recurrence-free survival

Time frame: the interval from breast cancer diagnosis to the initial recurrence or death upto 5 years

locoregional recurrence, distant metastasis, any cause of death

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2018
Study completion: 2018
First posted: Nov 29, 2023
Registry last updated: Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed