Omission of axillary lymph node dissection in ultrasound-detectable axillary metastases in primary breast cancer treated by upfront surgery: prospective randomized SENOMAC-ULTRA non-inferiority trial
In brief
Large trial to see if targeted axillary surgery can replace full dissection
The international SENOMAC-ULTRA study will randomize 1,380 women with stage II-III breast cancer and ultrasound-detected nodal metastases to either targeted axillary dissection or standard axillary lymph-node dissection. It aims to prove non-inferior recurrence-free survival over five years while reducing arm morbidity, but results are not expected for several years.
- Journal
- BJS open (Q1)
- Published
- 3 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Jana de Boniface, Tuomo Meretoja, Lisa Rydén, Malin Sund, Per Karlsson, Chiun-Sheng Huang, et al.
- PMID
- 42551036
- DOI
- 10.1093/bjsopen/zrag083
Why clinicians should know about it
- Picked for Radiology, Radiation Oncology, Nuclear Medicine, Medical Physics and Imaging (top studies of the week, 9 August 2026): High-quality evidence in a top journal
- Picked for Anatomy (top studies of the week, 9 August 2026): Not anatomy-focused, incidental relevance
- Picked for Dermatology (top studies of the week, 9 August 2026): Axillary lymph node dissection omission trial in breast cancer, surgery
- Picked for Pathology and Forensic Medicine (top studies of the week, 9 August 2026).
Abstract
BACKGROUND: Axillary lymph node dissection (ALND) in breast cancer causes substantial arm morbidity and long-term functional impairment. Less extensive axillary surgery, such as targeted axillary dissection (TAD), significantly reduces this risk. Although omission of ALND is standard in clinically node-negative disease with limited sentinel node involvement, this is not the case for patients with clinically node-positive disease undergoing upfront surgery. The aim of the SENOMAC-ULTRA trial is to evaluate whether TAD can safely replace ALND in patients with clinically node-positive breast cancer receiving upfront surgery. METHODS: SENOMAC-ULTRA is a prospective, international, multicentre, randomized non-inferiority trial. Adults with stage II-III invasive breast cancer and axillary metastases detectable by ultrasound and confirmed by fine needle aspiration or core biopsy are eligible for inclusion. Participants are randomized 1 : 1 to TAD (removal of marked metastatic nodes plus sentinel lymph node biopsy) or standard ALND. The primary endpoint is recurrence-free survival, assessed for non-inferiority using a Cox proportional hazards model. Secondary endpoints include overall survival, locoregional recurrence, regional nodal recurrence, distant relapse-free survival, invasive breast cancer-free survival, patient-reported arm morbidity, and health-related quality of life, as well as performance measures of axillary ultrasound and marking techniques. A sample size of 1380 patients has been calculated to provide 81% power to exclude a hazard ratio > 1.47 for recurrence-free survival at 5 years, adopting a non-inferiority margin of 4.5%. Follow-up is planned for 10 years. The trial protocol has been approved by the Swedish Ethical Review Authority (Dnr 2025-07730-01); each participating country will obtain local ethics approval. CONCLUSION: It is anticipated that the SENOMAC-ULTRA trial will fill an important knowledge gap guiding the surgical management of patients with clinically node-negative breast cancer. Registration number: NCT06869629 (https://clinicaltrials.gov).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.