Clinical trial · Observational
NO AXILLARY SURGERY IN EARLY BREAST CANCER (OXIGENATE)
NO AXILLARY SURGERY IN EARLY BREAST CANCER
NCT07370571CI-TRIAL-00101679OXIGENATEnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omission SLN | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Early stage breast cancer ptients with omission of sentinel node biopsy
- interventionNames
- Procedure: Omission SLN
Primary outcomes (2)
- measure
- Axillary Recurrence
- timeFrame
- from enrollement to the end of follow up 5 years
- description
- Determine the clinical efficacy of omitting a SLN i
- measure
- 3 year axillary recurrence
- timeFrame
- 3 years
- description
- Identify if patients with no axillary surgery had an increased axillary recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.