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Clinical Trial Summary

Italian Multicentric non inferiority two-arm randomized clinical trial to verify that the experimental treatment (omission of axillary lymph node intervention) in the presence of sentinel lymph node metastases does not lead to a significant worsening in survival or in the risk of locoregional recurrence compared to standard treatment (removal of I-II level of axillary lymph nodes).


Clinical Trial Description

Detailed Description: The trial is a non-inferiority trial; patients, depending on intra-operative or post-operative sentinel lymph node assessment, are randomly assigned to one of the two intervention groups: group 1: removal of I-II level of axillary lymph nodes (standard treatment). Removal of at least 10 lymph nodes is recommended. group 2: no axillary lymph nodes dissection (experimental treatment). Patients for whom sentinel lymph node cannot be found, will undergo complete dissection of the axillary cavity as required by international guidelines. After surgery, according to their bio-pathological profile and to the international guidelines criteria, patients will be able to receive: - no further treatment - complementary radiotherapy - adjuvant medical therapy (chemo and / or hormone therapy). Patients will be checked for at least 5 years in the following ways: - six-monthly clinical examination for the first 5 years and yearly thereafter - mammography + annual breast ultrasound - annual axillary ultrasound in cases not subjected to dissection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05160324
Study type Interventional
Source Fondazione Humanitas per la Ricerca
Contact
Status Active, not recruiting
Phase N/A
Start date April 14, 2015
Completion date April 30, 2025

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