Sentinel Node Vs Observation After Axillary Ultra-souND

The hypothesis of this trial are that: * avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients * pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden. The aims of this prospective randomized study are: * to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared * to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status * to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.

Sex

Female

Inclusion Criteria:

* breast cancer \<2 cm, and a clinically negative axilla
* any age
* candidates to receive breast conserving surgery + radiotherapy
* negative preoperative assessment of the axilla (ultra-sound with or without FNAC in case one doubtful node is found)
* written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
* patients must be accessible for follow-up.

Exclusion Criteria:

* synchronous distant metastases
* previous malignancy
* bilateral breast cancer
* multicentric or multifocal breast cancer
* previous primary systemic therapy
* pregnancy or breastfeeding
* pre-operative diagnosis (cytology or histology) of axillary lymph node metastases
* pre-operative radiological evidence of multiple involved or suspicious nodes
* patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

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• BACKGROUNDGalimberti V, Botteri E, Chifu C, Gentilini O, Luini A, Intra M, Baratella P, Sargenti M, Zurrida S, Veronesi P, Rotmensz N, Viale G, Sonzogni A, Colleoni M, Veronesi U. Can we avoid axillary dissection in the micrometastatic sentinel node in breast cancer? Breast Cancer Res Treat. 2012 Feb;131(3):819-25. doi: 10.1007/s10549-011-1486-2. Epub 2011 Apr 6. PMID 21468637
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• BACKGROUNDGiuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.