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NCT06869629 | NOT YET RECRUITING | Breast Carcinoma

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

Karolinska Institutet

Information provided by (Responsible Party):

Jana de Boniface

Brief Summary:

SENOMAC-ULTRA enrols patients with 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, offers non-inferior survival outcomes to a full axillary lymph node dissection.

Condition or disease

Breast Carcinoma

Breast Cancer

Breast Surgery

Intervention/treatment

Targeted axillary dissection

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 1152 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : SENOMAC-ULTRA: A Prospective Randomised Trial on the Omission of Axillary Lymph Node Dissection in Ultrasound-detected Axillary Metastases in Primary Breast Cancer
Actual Study Start Date : 2026-01-01
Estimated Primary Completion Date : 2030-12-31
Estimated Study Completion Date : 2040-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients with primary invasive breast cancer cT1-T3
  • * Axillary metastases detected by ultrasound (other imaging accepted if confirmatory ultrasound is performed)
  • * Axillary metastasis confirmed by fine needle or core biopsy
  • * Written informed consent
  • * Age ≥ 18 years
Exclusion Criteria
  • * Distant metastases
  • * Nodal metastases in ipsilateral axillary levels 3 or 4
  • * Preoperative suspicion of extensive nodal involvement, i.e. locally advanced disease
  • * Clinically N2-3 disease on palpation or imaging (i.e. nodes fixed to each other or to neighbouring structures)
  • * History of prior invasive breast cancer
  • * Bilateral invasive breast cancer
  • * Pregnancy or breast-feeding
  • * Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy \
  • * Medical contraindications for 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
Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

Location Details

NCT06869629

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