[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621434":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":28,"overallOfficials":17,"centralContacts":33,"locations":17,"responsibleParty":39,"collaborators":17,"id":43,"slug":17,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":17,"enrollmentInfo":52,"targetDuration":55,"studyType":56,"phases":17,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":17,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":17},{"fullName":5,"class":6},"Clinica Universidad de Navarra, Universidad de Navarra","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Axillary Recurrence","Determine the clinical efficacy of omitting a SLN i","from enrollement to the end of follow up 5 years",{"measure":14,"description":15,"timeFrame":16},"3 year axillary recurrence","Identify if patients with no axillary surgery had an increased axillary recurrence","3 years",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","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.","Early stage breast cancer patients with omission of SLN",[24],{"label":25,"type":17,"description":17,"interventionNames":26},"Early stage breast cancer ptients with omission of sentinel node biopsy",[27],"Procedure: Omission SLN",[29],{"type":30,"name":31,"description":31,"armGroupLabels":32,"otherNames":17},"PROCEDURE","Omission SLN",[25],[34],{"name":35,"role":36,"phone":37,"phoneExt":17,"email":38},"Isabel T Rubio, MD, PhD","CONTACT","+34620226830","irubior@unav.es",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Isabel Rubio","MD","100621434",false,"NCT07370571","NO AXILLARY SURGERY IN EARLY BREAST CANCER (OXIGENATE)","NO AXILLARY SURGERY IN EARLY BREAST CANCER","OXIGENATE","Inclusion Criteria:\n\nOlder than 18 years old cT1-2 cN0 Negative preoperative assessment of the axilla Breast surgery as first treatment No axillary surgery Multifocal\u002F 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.\n\nPatients must be accessible for follow-up.\n\nExclusion 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.","ALL","18 Years",{"count":53,"type":54},827,"ESTIMATED","1 Year","OBSERVATIONAL","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.",[59],"Breast Cancer",[61],"omission SLN, breast cancer","NOT_YET_RECRUITING","2026-01-17",{"date":65,"type":66},"2026-01-27","ACTUAL",{"date":68,"type":54},"2026-03-01",{"date":70,"type":54},"2032-03-30",{"name":5,"class":6}]