NO AXILLARY SURGERY IN EARLY BREAST CANCER (OXIGENATE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omission SLN.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NO AXILLARY SURGERY IN EARLY BREAST CANCER
Overview
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.
Interventions
- Procedure Omission SLN
Omission SLN
Primary outcome measures
- Axillary Recurrence [Time frame: from enrollement to the end of follow up 5 years]
- 3 year axillary recurrence [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07370571 · OXIGENATE