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Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement

Recruitingn/aAges 18 Years - 90 YearsAllEuropean Institute of Oncology
NCT07278726 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Upfront Targeted Axillary Dissection (UTAD)
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Where

14 sites
IRCCS AOU di Bologna - Policlinico di Sant'Orsola
Bologna, Italy
AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni
Forlì, Italy
European Institute of Oncology
Milan, Italy
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Presidio Ospedaliero "G. Bernabeo"
Ortona, Italy
Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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