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Not yet recruiting NCT06869629

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

No phase Interventional Breast Carcinoma Breast Cancer Breast Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Targeted axillary dissection, Axillary lymph node dissection.
Who it may be relevant to
Registry conditions: Breast Carcinoma, Breast Cancer, Breast Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SENOMAC-ULTRA: A Prospective Randomised Trial on the Omission of Axillary Lymph Node Dissection in Ultrasound-detectable Axillary Metastases in Primary Breast Cancer Treated by Upfront Surgery

Overview

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

  • Procedure Targeted axillary dissection
    Known metastases are marked before surgery and removed together with a sentinel lymph node biopsy
  • Procedure Axillary lymph node dissection
    Routine axillary clearance removing about 10+ lymph nodes from axillary levels I and II

Primary outcome measures

  • Recurrence-free survival [Time frame: 5 years]
Secondary outcome measures (4)
  • Arm morbidity [Time frame: 1, 3, 5 years]
  • Health-related quality of life [Time frame: 1, 3, 5 years]
  • Overall survival [Time frame: 5 years]
  • Health-related quality of life - breast cancer [Time frame: 1, 3, 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06869629 · SENOMAC-ULTRA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗