Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse
Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse
Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients
 with clinically node-negative breast cancer.

 Breast-conserving surgery (BCS) has also been a standard treatment for patients with early
 breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast
 tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally
 performed.

 There are no specific guidelines available regarding staging and treatment of the regional
 lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with
 local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is
 too high to be ignored.

 Moreover, evaluation of the regional lymph node basins might be helpful to decide on the
 indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems
 sensible to perform a regional lymph node staging procedure in patients with locally
 recurrent breast cancer.

 In general practice, this would mean that patients with recurrent breast cancer and a
 previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND)
 and that patients with a previous ALND would receive no additional axillary staging.

 Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it
 remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is
 technically feasible and ALND can safely be omitted.

 In this study, investigators propose for all patients the realization of SLNB procedure and
 systematically ALND whatever the results of SLNB analysis, only on patients previously
 treated with breast conservative surgery.

 The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of
 patients the feasibility and the accuracy of a second SLNB procedure for IBTR.
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
 .

 The primary objective is to evaluate the feasibility and the accuracy of a second SLNB in
 IBTR.

 The secondary objective are :

 1. The frequency of lymph node involvement

 2. The impact of axillary involvement on the therapeutic strategy, in particular
 radiotherapy

 3. Evaluation of extra-axillary lymphatic drainage

 4. The correlation between the detection rate of sentinel lymph node and the delay, in
 months, between the end of primary cancer radiotherapy and recurrence

 5. The occurrence of 5-year-old locoregional lymph node recurrence

 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.
Inclusion Criteria:

 1. Patients ≥ 18 years old

 2. Invasive recurrence (ductal, lobular, other), homolateral breast carcinoma

 3. Size of the tumor with ultrasound ≤ 5cm

 4. Initial conservative surgery

 5. Procedure for the detection of lymph node sentinel by isotopic method +/- colorimetric

 6. Minimum delay of one year between the end of radiotherapy for initial breast carcinoma
 and the treatment / management of ipsilateral recurrence

 7. Pregnancy test (urinary or blood) negative for premenopausal patients

 8. Information of the patient and obtaining written consent, signed by the patient and
 the investigator

 Exclusion Criteria:

 1. Non-invasive recurrence

 2. History of ipsilateral axillary dissection

 3. History of ipsilateral mastectomy

 4. Patient pN + before surgery

 5. Metastasis

 6. Patient pT4

 7. Allergy known to 2 detection products (Blue and radioactive tracer)

 8. Pregnant or lactating woman

 9. Patient protected or under guardianship or unable to give consent

 10. Impossibility of submitting to the medical examination for geographical, social or
 psychological reasons