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NCT Number: NCT06869629

Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

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.

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Key information

Conditions

Breast Carcinoma Breast Cancer Breast Diseases Breast Neoplasms Breast Surgery Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Axillary Dissection

Procedure

Known metastases are marked before surgery and removed together with a sentinel lymph node biopsy

Axillary Lymph Node Dissection

Procedure

Routine axillary clearance removing about 10+ lymph nodes from axillary levels I and II

Primary outcomes

  1. Recurrence-free survival

    Time frame: 5 years

    Time to event where an event is death if any cause or a recurrence of breast cancer

Secondary outcomes

  1. 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".

  2. 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.

  3. Overall survival

    Time frame: 5 years

    Time to event where an event is death of any cause

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jana de Boniface, Professor

CONTACT

[email protected]

+46702472305

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Acronym: SENOMAC-ULTRA

Important dates

Study start
2026
Primary completion
2030
Study completion
2040
First posted
Mar 11, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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