Breast CarcinomaSENOMAC-ULTRANCT06869629
Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer
A study testing Targeted axillary dissection and Axillary lymph node dissection in people with Breast Carcinoma and Breast Cancer, run by Karolinska Institutet at 4 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Breast Cancer, Breast Surgery
- What is being tested?
- Targeted axillary dissection and Axillary lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,380 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 13 May 2026to 31 Dec 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Sweden2 sites, 2 recruiting
- Recruiting
Skåne University Hospital
Malmö
Lisa Rydén, lisa.ryden@med.lu.se
- Recruiting
Örebro University Hospital
Örebro
Åsa Wickberg, asa.wickberg@regionorebrolan.se
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Tuomo Meretoja, tuomo.meretoja@hus.fi
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Jai-min Ryu, jaimin.ryu@samsung.com
About this study
Official title: 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.
- Conditions
- Breast Carcinoma, Breast Cancer, Breast Surgery
- Being tested
- Targeted axillary dissection, Axillary lymph node dissection
- Keywords
- axillary metastases, axillary lymph node dissection, targeted axillary dissection, sentinel lymph node biopsy, axillary ultrasonography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted axillary dissectionProcedure or surgery
Known metastases are marked before surgery and removed together with a sentinel lymph node biopsy
Axillary lymph node dissectionProcedure or surgery
Routine axillary clearance removing about 10+ lymph nodes from axillary levels I and II
| Study group | Role | What they receive |
|---|---|---|
| Axillary lymph node dissection | Active comparator | Axillary lymph node dissection Receives: Procedure: Axillary lymph node dissection |
| Targeted axillary dissection | Experimental | Removal of the marked metastasis/-es and a sentinel lymph node biopsy Receives: Procedure: Targeted axillary dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Time to event where an event is death if any cause or a recurrence of breast cancer
Measured: 5 years
Secondary outcomes (4)
Arm morbidity
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".
Measured: 1, 3, 5 years
Health-related quality of life
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.
Measured: 1, 3, 5 years
Overall survival
Time to event where an event is death of any cause
Measured: 5 years
Health-related quality of life - breast cancer
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.
Measured: 1, 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start13 May 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority open randomised design
- Masking
- None (open label)
- Enrolment
- 1,380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jana de Boniface, Karolinska Institutet
- Investigators
- Jana de Boniface, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869629
- Sponsor's protocol ID
- SENOMAC-ULTRA
- Acronym
- SENOMAC-ULTRA
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
de Boniface J, Meretoja T, Ryden L, Sund M, Karlsson P, Huang CS, Kim HJ, Ryu JM, Nash S, Offersen B, Dahl Nissen H, Wieslander E, Maggi N, Swedin L, Kuo SH, Tramm T, Dembrower K, Terata K, Nishibuchi I, Luna Tomas MA, Ciervide R, Lowery A, Skjerven HK, Ejlertsen B, Valachis A, Szulkin R, Spanic T, Shien T, Filtenborg Tvedskov T, Alkner S. 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. BJS Open. 2026 Jul 3;10(4):zrag083. doi: 10.1093/bjsopen/zrag083.
PubMed 42551036
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06869629
- Acronym / sponsor ID
- SENOMAC-ULTRA / SENOMAC-ULTRA
- Conditions
- Breast Carcinoma, Breast Cancer, Breast Surgery
- Keywords
- axillary metastases, axillary lymph node dissection, targeted axillary dissection, sentinel lymph node biopsy, axillary ultrasonography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,380 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority open randomised design
| Arm | Type | Receives |
|---|---|---|
| Axillary lymph node dissection | Active comparator | Procedure: Axillary lymph node dissectionAxillary lymph node dissection |
| Targeted axillary dissection | Experimental | Procedure: Targeted axillary dissectionRemoval of the marked metastasis/-es and a sentinel lymph node biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted axillary dissectionKnown metastases are marked before surgery and removed together with a sentinel lymph node biopsy | Procedure or surgery | Targeted axillary dissection |
| Axillary lymph node dissectionRoutine axillary clearance removing about 10+ lymph nodes from axillary levels I and II | Procedure or surgery | Axillary lymph node dissection |
Primary outcome
Recurrence-free survival
Time frame: 5 years
Time to event where an event is death if any cause or a recurrence of breast cancer
4 secondary outcomes
Arm morbidity
Time frame: 1, 3, 5 years
Health-related quality of life
Time frame: 1, 3, 5 years
Overall survival
Time frame: 5 years
Health-related quality of life - breast cancer
Time frame: 1, 3, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 42551036de Boniface J, Meretoja T, Ryden L, Sund M, Karlsson P, Huang CS, Kim HJ, Ryu JM, Nash S, Offersen B, Dahl Nissen H, Wieslander E, Maggi N, Swedin L, Kuo SH, Tramm T, Dembrower K, Terata K, Nishibuchi I, Luna Tomas MA, Ciervide R, Lowery A, Skjerven HK, Ejlertsen B, Valachis A, Szulkin R, Spanic T, Shien T, Filtenborg Tvedskov T, Alkner S. 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. BJS Open. 2026 Jul 3;10(4):zrag083. doi: 10.1093/bjsopen/zrag083.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jana de Boniface principal investigator
Karolinska Institutet
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted axillary dissection and Axillary lymph node dissection in people with Breast Carcinoma and Breast Cancer, run by Karolinska Institutet at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Finland, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jana de Boniface, Professor (+46702472305, jana.de-boniface@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.