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
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Please Select
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Seoul, Please Select, South Korea, 06273
- Gangnam Severance Hospital, Yonsei University College of Medicine
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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
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Immediately after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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.