Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse

FIGARO is a prospective multicentre phase-2 study that aims to evaluate technical feasibility and validity of performing second sentinel lymph node dissection (SLND) in patients with IBTR . To be included, patients must have a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before (time between the end of the previous radiotherapy and the diagnosis of recurrence). At time of recurrence, the patients must be evaluated by X-ray mammography and ultrasonography examination of breast and axilla, and a full general assessment to eliminate distant metastasis. Local recurrences will be operated by breast conservative surgery (BCS) or mastectomy. The decision between BCS and mastectomy will be carefully considered, in accordance with patient preference and other clinical features such as tumor location, tumor size, and breast size taken into account. Each patient will have a second SLNB followed by a systematic complete ALND. Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping. Lymphoscintigraphy will be performed according to previously reported standard techniques. At 2-20 h after lymphoscintigraphy, SLNB will be performed with or without a blue dye associated injection. An intraoperative gamma ray detection probe will be used during surgery to confirm locations of the sentinel nodes and to facilitate their removal. All sentinel nodes will be removed and sent for histopathologic examination according to previously described standard techniques. A complete ALND (Berg's stage I and II) will be realized and the nodes will be sent for standard histopathologic examination. Further systemic adjuvant therapies will be chosen in a multidisciplinary approach considering prognostic and predictive indicators. All the patients will be followed up for 5 years at 12-month intervals after the second surgery and undergo annual mammography with or without ultrasonography.