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RECRUITING
NCT07278726

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

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

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.

Official title: Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement: the UTAD Study of the Italian National Association of Breast Surgeons (ANISC)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-01-28

Completion Date

2033-11

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

PROCEDURE

Upfront Targeted Axillary Dissection (UTAD)

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)

IRCCS AOU di Bologna - Policlinico di Sant'Orsola

Bologna, Italy, Italy

AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni

Forlì, Italy, Italy

European Institute of Oncology

Milan, Italy, Italy

Fondazione IRCCS Istituto Nazionale Tumori di Milano

Milan, Italy, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Italy, Italy

Presidio Ospedaliero "G. Bernabeo"

Ortona, Italy, Italy

Policlinico San Matteo

Pavia, Italy, Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, Italy

AO San Giovanni Addolorata

Roma, Italy, Italy

IRCCS Humanitas Research Hospital

Rozzano, Italy, Italy

Azienda sanitaria universitaria Giuliano Isontina

Trieste, Italy, Italy

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

Varese, Italy, Italy

Ente Ospedaliero Cantonale

Lugano, Switzerland, Switzerland