Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer (SENOMAC-ULTRA)

Karolinska Institute

Status: Not yet enrolling

Conditions: Breast Cancer; Breast Surgery; Breast Carcinoma

Treatments: Procedure: Targeted axillary dissection; Procedure: Axillary lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06869629

SENOMAC-ULTRA

Details and patient eligibility

About

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.

Enrollment: 1,380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria or (ii) both sides meet all inclusion criteria
• Pregnancy
• Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy <three months is allowed)
• Medical contraindications for or expressed preoperative wish to abstain from 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,380 participants in 2 patient groups

Axillary lymph node dissection

Active Comparator group

Description:

Axillary lymph node dissection

Treatment:

Procedure: Axillary lymph node dissection

Targeted axillary dissection

Experimental group

Description:

Removal of the marked metastasis/-es and a sentinel lymph node biopsy

Treatment:

Procedure: Targeted axillary dissection