Axillary Nodal Burden in HER2+ and TNBC

October 2, 2025 updated by: Joon Jeong, Gangnam Severance Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1571

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Please Select
      • Seoul, Please Select, South Korea, 06273
        • Gangnam Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with early-stage HER2-positive breast cancer or TNBC who had clinically node-negative status on preoperative ultrasonography and underwent upfront breast-conserving surgery (BCS) with axillary surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic axillary lymph node metastasis rate
Time Frame: Immediately after surgery
Immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

October 2, 2025

First Submitted That Met QC Criteria

October 2, 2025

First Posted (Estimated)

October 8, 2025

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2025-0126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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