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

Completed

• Conditions: Neoadjuvant Chemotherapy; Micrometastases

• Registration Number: NCT06149884
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study Start: 2006-09-01
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-29
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 978

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	the interval from breast cancer diagnosis to the initial recurrence or death upto 5 years	locoregional recurrence, distant metastasis, any cause of death