Omitting full axillary dissection when breast cancer has spread to armpit nodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SENOMAC-ULTRA enrolls adults with primary invasive breast cancer and imaging-confirmed axillary metastases who are planned for upfront surgery. Participants are randomized to receive targeted axillary dissection (removing the sentinel nodes and the known involved nodes) instead of a full axillary lymph node dissection that removes many nodes. The study aims to show non-inferior survival with the less extensive surgery while potentially lowering risks such as lymphedema and shoulder dysfunction. The approach leverages imaging and pathological confirmation to guide limited nodal removal. Eligible patients are required to have no distant metastases and to meet specific clinical criteria before surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting
• Skåne University Hospital
  Malmö, Sweden Recruiting
• Örebro University Hospital
  Örebro, Sweden Recruiting

Study contacts

• Principal investigator: Jana de Boniface — Karolinska Institutet
• Study coordinator: Jana de Boniface, Professor
• Email: jana.de-boniface@ki.se
• Phone: +46702472305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.