NO AXILLARY SURGERY IN EARLY BREAST CANCER (OXIGENATE) (OXIGENATE)

January 17, 2026 updated by: Isabel Rubio, Clinica Universidad de Navarra, Universidad de Navarra

NO AXILLARY SURGERY IN EARLY BREAST CANCER

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients with histologically confirmed invasive breast cancer and a negative axillary US who are candidates for omitting SLN biopsy or any axillary surgery will be informed about the possible participation in the study. The inclusion and exclusion criteria are verified by the investigator and written informed consent is obtained from the patient. Surgical treatment, pathological assessment and postoperative locoregional and systemic therapy should be conducted according to institutional and national standards. Since the OXYGENATE study in a non-interventional trial, the study sites do not deviate from their own institutional protocol at any timepoint. The follow up on patient status is conducted yearly during the first 5 years after surgery.

Study Type

Observational

Enrollment (Estimated)

827

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Isabel T Rubio, MD, PhD
  • Phone Number: +34620226830
  • Email: irubior@unav.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Early stage breast cancer patients with omission of SLN

Description

Inclusion Criteria:

Older than 18 years old cT1-2 cN0 Negative preoperative assessment of the axilla Breast surgery as first treatment No axillary surgery Multifocal/ multicentric breast cancer Candidates to receive breast conserving surgery Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.

Patients must be accessible for follow-up.

Exclusion Criteria Synchronous distant metastases Any axillary surgery Neoadjuvant treatment Previous malignancy Bilateral breast cancer Previous primary systemic therapy Pregnancy or breastfeeding Pre-operative diagnosis (cytology or histology) of axillary lymph node metastases Pre-operative radiological evidence of multiple involved or suspicious nodes Patients with psychiatric, addictive, or any disorder, which compromises their ability to give informed consent for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early stage breast cancer ptients with omission of sentinel node biopsy
Procedure: Omission SLN
Omission SLN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axillary Recurrence
Time Frame: from enrollement to the end of follow up 5 years
Determine the clinical efficacy of omitting a SLN i
from enrollement to the end of follow up 5 years
3 year axillary recurrence
Time Frame: 3 years
Identify if patients with no axillary surgery had an increased axillary recurrence
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2032

Study Registration Dates

First Submitted

January 17, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXIGENATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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