Targeted removal of a marked lymph node for early hormone-receptor positive breast cancer with limited node spread

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

This trial tests whether removing the pre-marked suspicious lymph node along with the sentinel lymph node during initial surgery lets people with early ER+/PR+ HER2‑ breast cancer and 1–2 suspicious nodes avoid a full axillary lymph node dissection.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: European Institute of Oncology (Academic / other)
• Drugs / interventions: radiation
• Locations: 14 sites (Bologna, Italy and 13 other locations)
• Trial ID: NCT07278726 on ClinicalTrials.gov

What this trial studies

Patients with T0–T2 ER+/PR+ HER2– breast cancer who have 1–2 suspicious axillary nodes on ultrasound and at least one biopsy-confirmed positive node undergo upfront surgery with targeted axillary dissection, which removes the pre-marked suspicious node plus sentinel lymph node(s). A marker is placed in the most suspicious node preoperatively so that it can be reliably retrieved at surgery and combined with sentinel node review to reduce false negatives. Axillary lymph node dissection is performed only if three or more sentinel nodes are positive, aiming to reduce unnecessary extensive surgery. The protocol follows the latest NCCN guideline criteria to minimize overtreatment while preserving accurate staging.

Who should consider this trial

Good fit: Ideal candidates are people aged 18–90 with T0–T2 ER+/PR+ HER2– breast cancer, 1–2 suspicious axillary nodes on ultrasound with at least one biopsy-confirmed positive node, not planned for neoadjuvant therapy, and willing to attend follow-up.

Not a fit: Patients with three or more positive sentinel nodes, prior invasive breast cancer, recent other invasive malignancies, contraindications to radiation, or those requiring neoadjuvant therapy are unlikely to benefit from this approach.

Why it matters

Potential benefit: Patients could avoid a full axillary lymph node dissection and its complications, such as lymphedema and longer recovery, if targeted removal provides accurate staging.

How similar studies have performed: Targeted axillary dissection and marked-node techniques have shown promise in reducing the need for full ALND in related settings, though evidence specifically for upfront surgery in luminal cancers is still limited.

Eligibility criteria

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

Where this trial is running

Bologna, Italy and 13 other locations

• IRCCS AOU di Bologna - Policlinico di Sant'Orsola — Bologna, Italy, Italy (Not_yet_recruiting)
• AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni — Forlì, Italy, Italy (Not_yet_recruiting)
• European Institute of Oncology — Milan, Italy, Italy (Recruiting)
• Fondazione IRCCS Istituto Nazionale Tumori di Milano — Milan, Italy, Italy (Not_yet_recruiting)
• Azienda Ospedaliera Universitaria Federico II — Naples, Italy, Italy (Not_yet_recruiting)
• Presidio Ospedaliero "G. Bernabeo" — Ortona, Italy, Italy (Not_yet_recruiting)
• Policlinico San Matteo — Pavia, Italy, Italy (Not_yet_recruiting)
• Azienda Ospedaliera Universitaria Pisana — Pisa, Italy, Italy (Not_yet_recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy, Italy (Not_yet_recruiting)
• AO San Giovanni Addolorata — Roma, Italy, Italy (Not_yet_recruiting)
• IRCCS Humanitas Research Hospital — Rozzano, Italy, Italy (Recruiting)
• Azienda sanitaria universitaria Giuliano Isontina — Trieste, Italy, Italy (Not_yet_recruiting)
• ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi — Varese, Italy, Italy (Not_yet_recruiting)
• Ente Ospedaliero Cantonale — Lugano, Switzerland, Switzerland (Not_yet_recruiting)

Study contacts

• Study coordinator: Viviana Galimberti, MD

Conditions ALND; Sentinel Lymph Node Biopsy; Targeted Axillary Dissection