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.
