Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Targeted axillary dissection
Procedure/SurgeryKnown metastases are marked before surgery and removed together with a sentinel lymph node biopsy
Axillary lymph node dissection
Procedure/SurgeryRoutine axillary clearance removing about 10+ lymph nodes from axillary levels I and II
Treatment groups
1,380 Participants
are divided into 2 treatment groupsGroup A: Axillary lymph node dissectionActive comparator 1 intervention
Group B: Targeted axillary dissectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence-free survival
Time to event where an event is death if any cause or a recurrence of breast cancer
Time frame
5 yearsSecondary outcomes
1
Arm morbidity
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".
Time frame
1, 3, 5 years2
Health-related quality of life
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.
Time frame
1, 3, 5 years3
Overall survival
Time to event where an event is death of any cause
Time frame
5 years4
Health-related quality of life - breast cancer
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.
Time frame
1, 3, 5 yearsSponsors and contacts
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Source ClinicalTrials.gov