Patient characteristics, study design, and endpoints
tumour
TUMOUR
The SINODAR-ONE multicentre RCT was registered at ClinicalTrials.gov (ID NCT05160324) and approved by the institutional review boards of all participating centres. All patients provided written informed consent for treatment and clinical data acquisition. Patients with histologically confirmed invasive BC with a tumour size less than or equal to 5 cm, cN0, and no more than two metastatic SLNs were eligible for participation. In the present analysis, only patients operated on with mastectomy were included. The study design and endpoints have been described elsewhere