RecruitingNCT07278726

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)


Sponsor

European Institute of Oncology

Enrollment

150 participants

Start Date

Jan 28, 2026

Study Type

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a newer, more targeted approach to armpit (axillary) lymph node removal called Targeted Axillary Dissection (TAD) can safely replace full lymph node dissection in women with early-stage hormone receptor-positive breast cancer with limited lymph node involvement. **You may be eligible if...** - You are 18–90 years old - You have early-stage breast cancer (T0–T2, ER+/PR+, HER2-negative) - Only 1 or 2 lymph nodes under the arm look suspicious, and at least one has been confirmed positive by biopsy - You are not receiving neoadjuvant (pre-surgery) treatment - You are willing to follow the study procedures and attend follow-ups **You may NOT be eligible if...** - You have a history of invasive breast cancer - You have another invasive cancer diagnosed in the past 5 years - You have conditions that make radiation therapy unsafe - You have a psychiatric or other condition that would affect your ability to consent or participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREUpfront 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07278726


Related Trials