Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorEuropean Institute of Oncology
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
Sponsors and collaborators
Source ClinicalTrials.gov