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: Begins enrollment in 6 months

Conditions: Breast Cancer; Breast Surgery; Breast Carcinoma

Treatments: Procedure: Targeted axillary dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06869629

SENOMAC-ULTRA

Details and patient eligibility

About

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.

Enrollment: 1,152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,152 participants in 2 patient groups

Axilary lymph node dissection

No Intervention group

Description:

Routine upfront axillary lymph node dissection

Targeted axillary dissection

Experimental group

Description:

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

Treatment:

Procedure: Targeted axillary dissection