Axillary Nodal Burden in HER2+ and TNBC

NCT ID: NCT07211451

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1571 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Breast conserving surgery with axillary surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joon Jeong

Professpr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, Please Select, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2025-0126

Identifier Type: -

Identifier Source: org_study_id

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