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

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…

ClinicalTrials.gov IDNCT07278726

PhaseNot Applicable

Enrollment150

SponsorEuropean Institute of Oncology

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

ALND, Sentinel Lymph Node Biopsy (SLNB), Targeted Axillary Dissection (TAD)

About this study

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.

Primary outcomes

Successful rate of the retrieval of the deflector. (Perioperative/Periprocedural)
Prevention of Axillary Lymph Node Dissection (Perioperative/Periprocedural)

Eligibility information

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 locations

IRCCS AOU di Bologna - Policlinico di Sant'Orsola, Bologna, Italy 40138 Italy
AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni, Forlì, Italy 47121 Italy
European Institute of Oncology, Milan, Italy 20141 Italy
Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy 20133 Italy
Azienda Ospedaliera Universitaria Federico II, Naples, Italy 80131 Italy
Presidio Ospedaliero "G. Bernabeo", Ortona, Italy 66026 Italy
Policlinico San Matteo, Pavia, Italy 27100 Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, Italy 56100 Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy 00136 Italy
AO San Giovanni Addolorata, Roma, Italy 00184 Italy

Showing 10 of 14 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.