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NCT07278726Recruiting

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

Official recordSimplified version

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland, Italy
Sponsor
European Institute of Oncology(Other)
Protocol no.
UID 5132
Conditions
ALND, Sentinel Lymph Node Biopsy (SLNB), Targeted Axillary Dissection (TAD)
Interventions
Procedure

Treatments studied

  • Upfront Targeted Axillary Dissection (UTAD)

Locations · 5

  • Forlì, ItalyAUSL Romagna - Presidio Ospedaliero Morgagni-PierantoniRecruiting at this site
  • Milan, ItalyEuropean Institute of OncologyRecruiting at this site
  • Pavia, ItalyPoliclinico San MatteoRecruiting at this site
  • Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting at this site
  • Rozzano, ItalyIRCCS Humanitas Research HospitalRecruiting at this site

In total, worldwide, 5 of the 14 sites listed in the registry are recruiting; the other 9 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: June 16, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • L2-439 · other identifier

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.