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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
889
Axillary dissection in patients with positive sentinel lymph node
Preservation of axillary lymph nodes in patients with positive sentinel lymph node
Overall Survival (OS)
Evaluating whether, in women operated for breast cancer (T1-T2) with sentinel lymph node metastases, axillary lymph node conservation is associated with a clinically relevant prognostic worsening (OS). For all the Outcomes Statistical analysis included Kaplan-Meier Product Limit Estimator and the log-rank test
Time frame: 5 years of follow up after surgery
Regional Disease Free Survival (RDFS)
Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase of local recurrence rate (ipsilateral axillary and supraclavicular lymph nodes).
Time frame: 5 years of follow up after surgery
Disease-free distance survival (DDFS)
Evaluating whether axillary lymph node preservation is associated with a clinically relevant increase in distant recurrence rate.
Time frame: 5 years of follow up after surgery
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