Clinical trial NCT06869629: Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Breast Cancer
Breast Surgery
Keywords: axillary metastases
axillary lymph node dissection
targeted axillary dissection
sentinel lymph node biopsy
axillary ultrasonography
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 1152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Arm morbidity
timeFrame: 1, 3, 5 years
measure: Health-related quality of life
timeFrame: 1, 3, 5 years
measure: Overall survival
timeFrame: 5 years
measure: Health-related quality of life - breast cancer
timeFrame: 1, 3, 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Jana de Boniface
role: PRINCIPAL_INVESTIGATOR
References: