Axillary Nodal Burden in HER2+ and TNBC

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, Please Select, 06273, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Breast conserving surgery with axillary surgery

Procedure

In this study, all patients received breast conserving surgery with axillary surgery.

Primary outcomes

Pathologic axillary lymph node metastasis rate

Time frame: Immediately after surgery

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Low Axillary Nodal Metastasis Rates in Selected HER2-Positive and Triple-Negative Breast Cancer Patients: Toward De-escalation of Sentinel Lymph Node Biopsy

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 8, 2025
Registry last updated: Oct 8, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.

Completed