NCT07370571

Brief Summary

Prospective study will establish a comprehensive international registry specifically for patients who have undergone surgery for primary breast cancer without SLNB. The main objective of this registry is to gather detailed, real-world data on the outcomes of this particular treatment approach, providing insights into the clinical efficacy and quality of life of patients when SLNB is omitted.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
827

participants targeted

Target at P75+ for all trials

Timeline
72mo left

Started Mar 2026

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Mar 2032

First Submitted

Initial submission to the registry

January 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2032

Last Updated

January 27, 2026

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

January 17, 2026

Last Update Submit

January 17, 2026

Conditions

Breast Cancer

Keywords

omission SLN, breast cancer

Outcome Measures

Primary Outcomes (2)

  • Axillary Recurrence

    Determine the clinical efficacy of omitting a SLN i

    from enrollement to the end of follow up 5 years

  • 3 year axillary recurrence

    Identify if patients with no axillary surgery had an increased axillary recurrence

    3 years

Study Arms (1)

Early stage breast cancer ptients with omission of sentinel node biopsy

Procedure: Omission SLN

Interventions

Omission SLNPROCEDURE

Omission SLN

Early stage breast cancer ptients with omission of sentinel node biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Early stage breast cancer patients with omission of SLN

You may qualify if:

  • Patients must be accessible for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Isabel T Rubio, MD, PhD

CONTACT

+34620226830irubior@unav.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2032

Last Updated

January 27, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF