NCT07370571

NO AXILLARY SURGERY IN EARLY BREAST CANCER (OXIGENATE)

NO AXILLARY SURGERY IN EARLY BREAST CANCER

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 827 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Omission SLN	Omission SLN

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-30
• Completion: 2032-03-30
• First posted: 2026-01-27
• Last updated: 2026-01-27