Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement (UTAD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ALND; Sentinel Lymph Node Biopsy (SLNB); Targeted Axillary Dissection (TAD)
• Intervention / Treatment: Procedure: Upfront Targeted Axillary Dissection (UTAD)

Detailed Description

The patients that will avoid axillary lymph node dissection (ALND) meet all the criteria listed in the latest NCCN guidelines version.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Viviana Galimberti, MD; Phone Number: +39 0257489717; Email: viviana.galimberti@ieo.it

Study Locations

• Italy
  • Italy
    • Bologna, Italy, Italy, 40138
      • Not yet recruiting
      • IRCCS AOU di Bologna - Policlinico di Sant'Orsola
      • Contact: Marco Bernini, MD; Phone Number: +39 051 2143344; Email: marco.bernini@aosp.bo.it
      • Principal Investigator: Marco Bernini, MD
    • Forlì, Italy, Italy, 47121
      • Not yet recruiting
      • AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni
      • Principal Investigator: Annalisa Curcio, MD
      • Contact: Annalisa Curcio, MD; Phone Number: +39 0543731676; Email: annalisa.curcio@auslromagna.it
    • Milan, Italy, Italy, 20141
      • Recruiting
      • European Institute of Oncology
      • Contact: Viviana Galimberti, MD; Phone Number: +39 0257489717; Email: viviana.galimberti@ieo.it
      • Principal Investigator: Viviana Galimberti, MD
    • Milan, Italy, Italy, 20133
      • Not yet recruiting
      • Fondazione IRCCS Istituto Nazionale Tumori di Milano
      • Contact: Massimiliano Gennaro, MD; Phone Number: +39 0223902659; Email: Massimiliano.Gennaro@istitutotumori.mi.it
      • Principal Investigator: Massimiliano Gennaro, MD
    • Naples, Italy, Italy, 80131
      • Not yet recruiting
      • Azienda Ospedaliera Universitaria Federico II
      • Contact: Nicola Rocco, MD; Phone Number: +39 0817462896
    • Ortona, Italy, Italy, 66026
      • Not yet recruiting
      • Presidio Ospedaliero "G. Bernabeo"
      • Contact: Simona Grossi, MD; Phone Number: +39 085 9172228; Email: sgrossi@unich.it
      • Principal Investigator: Simona Grossi, MD
    • Pavia, Italy, Italy, 27100
      • Recruiting
      • Policlinico San Matteo
      • Contact: Angelica Della Valle, MD; Phone Number: +39 0328 501809; Email: A.DellaValle@smatteo.pv.it
      • Principal Investigator: Angelica Della Valle, MD
    • Pisa, Italy, Italy, 56100
      • Not yet recruiting
      • Azienda Ospedaliera Universitaria Pisana
      • Contact: Matteo Ghilli, MD; Phone Number: +39 050 993139; Email: m.ghilli@ao-pisa.toscana.it
      • Principal Investigator: Matteo Ghilli, MD
    • Roma, Italy, Italy, 00136
      • Not yet recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Contact: Gianluca Franceschini, MD; Phone Number: +39 06 9779 1378; Email: gianluca.franceschini@policlinicogemelli.it
      • Principal Investigator: Gianluca Franceschini, MD
    • Roma, Italy, Italy, 00184
      • Not yet recruiting
      • AO San Giovanni Addolorata
      • Contact: Lucio Fortunato, MD; Phone Number: +39 0677055112; Email: lfortunato@hsangiovanni.roma.it
      • Principal Investigator: Lucio Fortunato, MD
    • Rozzano, Italy, Italy, 20089
      • Recruiting
      • IRCCS Humanitas Research Hospital
      • Contact: Damiano Gentile, MD; Phone Number: +39 0282246252; Email: damiano.gentile@humanitas.it
      • Principal Investigator: Damiano Gentile, MD
    • Trieste, Italy, Italy, 34148
      • Not yet recruiting
      • Azienda Sanitaria Universitaria Giuliano Isontina
      • Contact: Serena Scomersi, MD; Phone Number: +39 040 3994152; Email: serena.scomersi@asugi.sanita.fvg.it
      • Principal Investigator: Serena Scomersi, MD
    • Varese, Italy, Italy, 21100
      • Not yet recruiting
      • ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
      • Contact: Corrado Chiappa, MD; Phone Number: +39 0332 278342; Email: corrado.chiappa@asst-settelaghi.it
      • Principal Investigator: Corrado Chiappa, MD
• Switzerland
  • Switzerland
    • Lugano, Switzerland, Switzerland, CH-6500
      • Not yet recruiting
      • Ente Ospedaliero Cantonale
      • Contact: Nickolas Peradze, MD; Phone Number: +41 (0)91 811 76 96; Email: Nickolas.Peradze@eoc.ch
      • Principal Investigator: Nickolas Peradze, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with T0-T1-T2 ER+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 positive nodal citology/histology) M0 for whom neoadjuvant treatment is not recommended after a multidisciplinary discussion, between 18 and 90 years old willing and able to follow the study procedures and available for follow-up over the entire duration of the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful rate of the retrieval of the deflector.	Number of successful retrieval of the deflector on the total number of surgeries.	Perioperative/Periprocedural
Prevention of Axillary Lymph Node Dissection	Total number of patient that did not received but were elegible for Axillary Lymph Node Dissection by the current guidelines on the total number of surgeries.	Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axillary recurrence rate	The secondary endpoint is the rate of axillary recurrence in patients undergoing UTAD and who avoid AD. Cumulative incidence of axillary recurrence as first event will be calculated, considering the following events as competing: distant metastases, death, second primary malignancies, invasive ipsilateral tumor recurrences in the breast or chest wall, supraclavicular or internal mammary recurrences, and contralateral invasive cancers.	5 years from surgery.

Collaborators and Investigators

• Sponsor: European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2033

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UID 5132; L2-439 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No