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

Launched by KAROLINSKA INSTITUTET · Mar 10, 2025

Keywords

ClinConnect Summary

The SENOMAC-ULTRA trial is studying a new approach for treating breast cancer that has spread to the lymph nodes in the armpit. Traditionally, doctors remove a large number of lymph nodes during surgery, but this can sometimes lead to complications, like swelling in the arm. This trial aims to see if removing just the first lymph node(s) and the known affected lymph nodes can provide similar health outcomes as the more extensive surgery, while avoiding unnecessary risks.

To participate in this trial, patients should be adults aged 18 and older with a specific type of breast cancer (stages T1 to T3) where lymph node involvement has been confirmed through ultrasound and biopsy. However, those with more advanced disease or other specific health issues may not be eligible. If you join the study, you will receive treatment based on the trial's approach and will be closely monitored by healthcare professionals. This trial offers a valuable opportunity to help improve breast cancer surgery and patient care in the future.

Gender

ALL

Eligibility 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 \<three months is allowed)
• • 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