Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement
Recruiting · NCT07278726 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Upfront Targeted Axillary Dissection (UTAD)
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
- 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 it is running
14 locations listed.
- IRCCS AOU di Bologna - Policlinico di Sant'Orsola - Bologna, Italy, Italy
- AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni - Forlì, Italy, Italy
- European Institute of Oncology - Milan, Italy, Italy
- Fondazione IRCCS Istituto Nazionale Tumori di Milano - Milan, Italy, Italy
- Azienda Ospedaliera Universitaria Federico II - Naples, Italy, Italy
- Presidio Ospedaliero "G. Bernabeo" - Ortona, Italy, Italy
- Policlinico San Matteo - Pavia, Italy, Italy
- Azienda Ospedaliera Universitaria Pisana - Pisa, Italy, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma, Italy, Italy
- AO San Giovanni Addolorata - Roma, Italy, Italy
- IRCCS Humanitas Research Hospital - Rozzano, Italy, Italy
- Azienda sanitaria universitaria Giuliano Isontina - Trieste, Italy, Italy
- ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi - Varese, Italy, Italy
- Ente Ospedaliero Cantonale - Lugano, Switzerland, Switzerland