Axillary Nodal Burden in HER2+ and TNBC | NCT07211451

Studies
Axillary Nodal Burden in HER2+ and TNBC

NCT07211451

Sponsor

Gangnam Severance Hospital

Status

Completed

Last Update Posted

Oct 8, 2025Actual

Enrollment

1,571Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Breast conserving surgery with axillary surgery

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Aug 31, 2025Actual

Completion Date

Sep 30, 2025Actual

First Submitted Date

Oct 2, 2025

First Submission Date that Met QC Criteria

Oct 2, 2025

First Posted Date

Oct 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2025

Last Update Posted Date

Oct 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,571Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breast conserving surgery with axillary surgery	Procedure	In this study, all patients received breast conserving surgery with axillary surgery.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangnam Severance Hospital, Yonsei University College of Medicine		Seoul	Please Select	06273	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D064726	Triple Negative Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015412	Mastectomy, Segmental

Ancestor Terms

ID	Term
D008408	Mastectomy
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided