Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit i… (NCT06869629) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer
1,380 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.