NCT07211451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,571

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

October 2, 2025

Last Update Submit

October 2, 2025

Conditions

Breast Cancer

Keywords

Breast cancerSentinel lymph node biopsyOmissionHER2Triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

  • Pathologic axillary lymph node metastasis rate

    Immediately after surgery

Interventions

Breast conserving surgery with axillary surgeryPROCEDURE

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

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients who underwent mastectomy
  • Absence of axillary nodal assessment on ultrasonography
  • Patients who underwent mastectomy
  • Patients who underwent mastectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, Please Select, 06273, South Korea

Location

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professpr

Study Record Dates

First Submitted

October 2, 2025

First Posted

October 8, 2025

Study Start

June 1, 2025

Primary Completion

August 31, 2025

Study Completion

September 30, 2025

Last Updated

October 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)