Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node involvement. These results lead us to consider the indication of the sentinel lymph node (SLN) technique after NAC in order to avoid unnecessary ALND in patients whose SLN is free of involvement. We need to validate the SLN technique after NAC in patients who have proven lymph node involvement prior to NAC. GANEA2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 (pN+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cN0). Patients of group 1, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
958
Group 2 : Patients without proven axillary involved nodes will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.
CHU
Angers, France
Institut de Cancerologie de L'Ouest
Angers, France
Institut Bergonié
Bordeaux, France
CHU
Brest, France
Centre Jean Perrin
Clermont-Ferrand, France
CH
La Roche-sur-Yon, France
Centre Oscar Lambret
Lille, France
Centre Léon Berard
Lyon, France
Institut Paoli Calmette
Marseille, France
INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle
Montpellier, France
...and 8 more locations
false-negative (FN) rate for the Sentinel Lymph Node Detection
Ratio of the number of FN cases to the total number of patients with at least one lymph node involved, sentinel or not. a FN case was defined as a patient with a successful mapping, SLN(s) without any metastasis, and a metastasis in at least one node from the ALND
Time frame: after surgery
Detection rate
Percentage of patients with SLN detected and isolated intraoperatively
Time frame: after surgery
Sataloff score on breast tumour
The Sataloff classification assesses the response of the NAC on the breast tissue. TA: total or almost total therapeutic effect. TB: therapeutic effect \> 50%. TC: \< 50% therapeutic effect but obvious effect. TD: no therapeutic effect
Time frame: after surgery
Sataloff score on lymph nodes
The Sataloff classification assesses the response of the NAC on the lymph nodes NA: clear therapeutic effect, no metastases. NB: no therapeutic effect, no metastases. NC: aspects of therapeutic effect, but presence of metastases. ND: no therapeutic effect, viable metastases.
Time frame: after surgery
Homolateral axillary recurrence rate
Recurrence observed groupe 2 patients (cN0) whitout ALND
Time frame: 5 years post surgery
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