Axillary Nodal Burden in HER2+ and TNBC

Completed

• Conditions: Breast Cancer

• Registration Number: NCT07211451
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

This study aimed to evaluated rates of pathologic axillary nodal metastasis in patients with with early-stage HER2-positive BC or TNBC who had clinically node-negative status on preoperative ultrasonography and underwent upfront breast-conserving surgery (BCS) with axillary surgery. In addition, this study aimed to identify subgroups in which SLNB omission may be feasible.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Primary Completion: 2025-08-31
• Status Verified: 2025-09
• Study Completion: 2025-09-30
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1571

Inclusion Criteria

• HER2-positive breast cancer or TNBC
• Patients who received upfront breast conserving surgery with axillary surgery
• Patients who had a clinically axillary node negative disease

Exclusion Criteria

• Patients who underwent mastectomy
• Absence of axillary nodal assessment on ultrasonography
• Patients who underwent mastectomy
• Patients who underwent mastectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic axillary lymph node metastasis rate	Immediately after surgery

Trial Locations

Locations (1)

Gangnam Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Please Select, South Korea