A Randomized clinical trial on sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer: results of the Sentinella/GIVOM trial.

Objective: The aim of this multicenter randomized trial was to assess the efficacy and safety of sentinel lymph node (SLN) biopsy compared with axillary lymph node dissection (ALND).

Background: All studies on SLN biopsy in breast cancer report a variable false negative rate, whose prognostic consequences are still unclear.

Methods: From May 1999 to December 2004, patients with breast cancer < or =3 cm were randomly assigned to receive SLN biopsy associated with ALND (ALND arm) or SLN biopsy followed by ALND only if the SLN was metastatic (SLN arm).