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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS AOU di Bologna - Policlinico di Sant'Orsola
NOT_YET_RECRUITING
Bologna
AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni
NOT_YET_RECRUITING
Forlì
European Institute of Oncology
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale Tumori di Milano
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
NOT_YET_RECRUITING
Naples
Presidio Ospedaliero G. Bernabeo
NOT_YET_RECRUITING
Ortona
Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Azienda Ospedaliera Universitaria Pisana
NOT_YET_RECRUITING
Pisa
AO San Giovanni Addolorata
NOT_YET_RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Roma
IRCCS Humanitas Research Hospital
RECRUITING
Rozzano
Azienda sanitaria universitaria Giuliano Isontina
NOT_YET_RECRUITING
Trieste
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
NOT_YET_RECRUITING
Varese
Switzerland
Ente Ospedaliero Cantonale
NOT_YET_RECRUITING
Lugano
Contact Information
Primary
Viviana Galimberti, MD
viviana.galimberti@ieo.it
+39 0257489717
Time Frame
Start Date: 2026-01-28
Estimated Completion Date: 2033-11
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov