Axillary Nodal Burden in HER2+ and TNBC

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07211451

Enrollment

1571

Registered

2025-10-08

Start date

2025-06-01

Completion date

2025-09-30

Last updated

2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Sentinel lymph node biopsy, Omission, HER2, Triple-negative breast cancer

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.

Interventions

PROCEDUREBreast conserving surgery with axillary surgery

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pathologic axillary lymph node metastasis rate	Immediately after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026