Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

NCT06869629 | Not Yet Recruiting DMC

• 1 other identifier: SENOMAC-ULTRA
• Study Type: interventional
• Target: 1,380
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Carcinoma; Breast Cancer; Breast Surgery

Keywords

axillary metastases; axillary lymph node dissection; targeted axillary dissection; sentinel lymph node biopsy; axillary ultrasonography

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  Time to event where an event is death if any cause or a recurrence of breast cancer

  5 years

Secondary Outcomes (4)

• Arm morbidity

  1, 3, 5 years

• Health-related quality of life

  1, 3, 5 years

• Overall survival

  5 years

• Health-related quality of life - breast cancer

  1, 3, 5 years

Study Arms (2)

Axillary lymph node dissection

ACTIVE COMPARATOR

Axillary lymph node dissection

Procedure: Axillary lymph node dissection

Targeted axillary dissection

EXPERIMENTAL

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

Procedure: Targeted axillary dissection

Interventions

Targeted axillary dissection PROCEDURE

Known metastases are marked before surgery and removed together with a sentinel lymph node biopsy

Targeted axillary dissection

Axillary lymph node dissection PROCEDURE

Routine axillary clearance removing about 10+ lymph nodes from axillary levels I and II

Axillary lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jana de Boniface

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana de Boniface, Professor

CONTACT

+46702472305; jana.de-boniface@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Non-inferiority open randomised design

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF