Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement
Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement: the UTAD Study of the Italian National Association of Breast Surgeons (ANISC)
European Institute of Oncology
150 participants
Jan 28, 2026
OBSERVATIONAL
Conditions
Summary
The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology/cytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.
Eligibility
Inclusion Criteria6
- Diagnosis of T0-T1-T2 ER+/PR+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 nodal positive cytology/histology)
- M0
- Conservative surgery or mastectomy
- Neoadjuvant treatment not recommended after a multidisciplinary discussion
- Patients between 18 and 90 years old
- Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study
Exclusion Criteria5
- Psychiatric, addictive or any disorder, which compromises ability to give informed consent for participation in the study
- Personal history of invasive breast cancer
- Other invasive malignancies diagnosed in the last five years
- Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion
- Contraindications to radiation therapy
Interventions
During the surgical intervention lymphnodes excised both with reflector localization and Gamma probe will be sent for pathological examination and only in case of more than 2 metastatic lymph nodes (and at least one of them with macrometastasis) axillary dissection will be performed.
Locations(14)
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NCT07278726