Breast Carcinoma, Breast Cancer, Breast Surgery
Conditions
Keywords
axillary metastases, axillary lymph node dissection, targeted axillary dissection, sentinel lymph node biopsy, axillary ultrasonography
Brief summary
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.
Interventions
PROCEDURETargeted axillary dissection
Known metastases are marked before surgery and removed together with a sentinel lymph node biopsy
PROCEDUREAxillary lymph node dissection
Routine axillary clearance removing about 10+ lymph nodes from axillary levels I and II
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-inferiority open randomised design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 5 years | Time to event where an event is death if any cause or a recurrence of breast cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactJana de Boniface, Professor
Outcome results
None listed