Actively Recruiting
Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement
Led by European Institute of Oncology · Updated on 2026-02-03
150
Participants Needed
14
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
IRCCS AOU di Bologna - Policlinico di Sant'Orsola
Bologna, Italy, Italy, 40138
Not Yet Recruiting
2
AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni
Forlì, Italy, Italy, 47121
Not Yet Recruiting
3
European Institute of Oncology
Milan, Italy, Italy, 20141
Actively Recruiting
4
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Italy, Italy, 20133
Not Yet Recruiting
5
Azienda Ospedaliera Universitaria Federico II
Naples, Italy, Italy, 80131
Not Yet Recruiting
6
Presidio Ospedaliero "G. Bernabeo"
Ortona, Italy, Italy, 66026
Not Yet Recruiting
7
Policlinico San Matteo
Pavia, Italy, Italy, 27100
Not Yet Recruiting
8
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, Italy, 56100
Not Yet Recruiting
9
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, Italy, 00136
Not Yet Recruiting
10
AO San Giovanni Addolorata
Roma, Italy, Italy, 00184
Not Yet Recruiting
11
IRCCS Humanitas Research Hospital
Rozzano, Italy, Italy, 20089
Actively Recruiting
12
Azienda sanitaria universitaria Giuliano Isontina
Trieste, Italy, Italy, 34148
Not Yet Recruiting
13
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
Varese, Italy, Italy, 21100
Not Yet Recruiting
14
Ente Ospedaliero Cantonale
Lugano, Switzerland, Switzerland, CH-6500
Not Yet Recruiting
Research Team
V
Viviana Galimberti, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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