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

Not Applicable

Not yet recruiting

• Conditions: Breast Carcinoma; Breast Cancer; Breast Surgery

• Registration Number: NCT06869629
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2026-01-01
• Primary Completion: 2030-12-31
• Study Completion: 2040-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	5 years	Time to event where an event is death if any cause or a recurrence of breast cancer

Secondary Outcome Measures

Name	Time	Method
Arm morbidity	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".
Health-related quality of life	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.
Overall survival	5 years	Time to event where an event is death of any cause
Health-related quality of life - breast cancer	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.