About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Upfront Targeted Axillary Dissection (UTAD)

Treatment groups

No treatment groups listed

Locations

14
Italy
IRCCS AOU di Bologna - Policlinico di Sant'Orsola40138, BolognaItaly, Italy
AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni47121, ForlìItaly, Italy
European Institute of Oncology20141, MilanItaly, Italy
Fondazione IRCCS Istituto Nazionale Tumori di Milano20133, MilanItaly, Italy

Sponsors and collaborators

European Institute of Oncology

Lead sponsor