Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer (SENOMAC-ULTRA)

August 13, 2026 updated by: Jana de Boniface, Karolinska Institutet

SENOMAC-ULTRA: A Prospective Randomised Trial on the Omission of Axillary Lymph Node Dissection in Ultrasound-detectable Axillary Metastases in Primary Breast Cancer Treated by Upfront Surgery

SENOMAC-ULTRA enrols patients who are planned for upfront surgery for a breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. In this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. More extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. This trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node/s in the armpit (the sentinel lymph node/s) and the known metastatic lymph nodes (targeted axillary dissection, TAD), offers non-inferior survival outcomes to a full axillary lymph node dissection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with primary invasive breast cancer clinical stage II-III
  • Palpable or non-palpable axillary metastases visible by ultrasound (other imaging accepted if confirmatory ultrasound is performed) and confirmed by fine needle aspiration or core biopsy
  • Written informed consent
  • Age ≥ 18 years

Exclusion Criteria:

  • Distant metastases
  • Ipsilateral metastases in internal mammary, infra- or supraclavicular lymph nodes without confirmed axillary nodal involvement
  • Preoperative suspicion of extensive nodal involvement, i.e. locally advanced disease
  • Nodes fixed to each other or to neighbouring structures on palpation or imaging
  • History of contralateral invasive breast cancer within 5 years
  • Bilateral invasive breast cancer if (i) one side meets any exclusion criteria or (ii) both sides meet all inclusion criteria
  • Pregnancy
  • Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy <three months is allowed)
  • Medical contraindications for or expressed preoperative wish to abstain from radiotherapy or the recommended adjuvant systemic treatment which complies with standard of care, taking age and comorbidity into consideration
  • Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Axillary lymph node dissection
Procedure: Axillary lymph node dissection
Routine axillary clearance removing about 10+ lymph nodes from axillary levels I and II
Experimental: Targeted axillary dissection
Removal of the marked metastasis/-es and a sentinel lymph node biopsy
Procedure: Targeted axillary dissection
Known metastases are marked before surgery and removed together with a sentinel lymph node biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 5 years
Time to event where an event is death if any cause or a recurrence of breast cancer
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm morbidity
Time Frame: 1, 3, 5 years
Arm function as reported by patients via the Lymphedema Functioning, Disability and Health questionnaire (Lymph-ICF), which consists of 29 questions about impairments in function, activity limitations, and participation restrictions of patients with breast cancer and arm lymphedema. The questionnaire is divided into 5 domains: physical function, mental function, household activities, mobility activities, and life and social activities. Each item is scored on a visual analogue scale (0-100 mm) resulting in domain scores ranging from 0 to 100. Higher scores indicate more severe arm dysfunction. Lymph-ICF scores also categorize into "no problem", "a small problem", "a moderate problem", "a severe problem", and "a very severe problem".
1, 3, 5 years
Health-related quality of life
Time Frame: 1, 3, 5 years
Health-related quality of life measured by EORTC C30. The EORTC QLQ-C30 questionnaire measures HRQoL among cancer patients in general and consists of 30 items divided into multi-item scales and single items. The multi-item scales include one global health and quality of life (QoL) scale, five function subscales (physical, role, emotional, cognitive, social) and three symptom subscales (fatigue, nausea and vomiting, pain). The single items are dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties. Each scale produces a total score from 0 to 100. High scores on functional subscales indicate better function, and high scores on symptom subscales indicate more severe problems.
1, 3, 5 years
Overall survival
Time Frame: 5 years
Time to event where an event is death of any cause
5 years
Health-related quality of life - breast cancer
Time Frame: 1, 3, 5 years
The EORTC QLQ-BR23 questionnaire measures functions and symptoms related to breast cancer treatment and consists of 23 items divided into two functional subscales (body image and sexuality) and three symptom subscales (systemic therapy side effects, arm symptoms, breast symptoms) and three single items (sexual enjoyment, upset by hair loss, future perspective). The functional and symptom subscales as well as the single items correspond to a response scale 1-4 (not at all, a little, quite a bit, very much). Each scale produces a total score from 0 to 100. High scores on functional subscales indicate better function, and high scores on symptom subscales indicate more severe problems.
1, 3, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Jana de Boniface, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2041

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENOMAC-ULTRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD may be shared upon reasonable request and with all relevnt legal and ethical requirements fulfilled. No request will be accepted before the publication of the primary endpoint.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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