Etude : GANEA 3 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : GANEA 3

Nom :

Traitement : Chirurgie

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 27/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Ganglion sentinelle Après chimiothérapie NEoAdjuvante dans le cancer du sein

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : GANEA3 is a prospective multicenter diagnostic study assessing the benefit of targeting initial involved node in complement to SLND and breast tumor characteristics to predict axillary status after NAC.

The diagnostic performances of this strategy will be primarily assessed by the decrease of the FNR with the combined strategy compared to SLND alone.

The primary objective is to evaluate the interest of identifying, before NAC, the initial involved lymph node to improve the prediction of axillary status after NAC.

The main secondary objectives are :
- To assess the feasibility, at the time of the surgery, of the identification and resection of the initially involved lymph node, tagged with the metal clip before NAC ;
- To evaluate the complications related to the setting up of the metal clip for the identification of a lymph node metastatic ;
- To evaluate the interest and impact of immunohistochemical analysis of tagged lymph node and SLN ;

Patients treated for a large early breast cancer (BC) needing NAC undergo axillary sonography assessment routinely performed to seek suspicious nodes. When several suspicious nodes are found only the worst is chosen. A fine needle aspiration is performed to allow cytological examination (biopsy is optional) of the suspicious node. In case of proven axillary involvement, the patient is informed about GANEA 3 study in order to be included.

At this step the patient must accept the study and sign the consent form. The involved node is then tagged (with a metal clip) under sonography. In case of multiple suspicious nodes, the radiologist must choose the worst node in order to tag only one involved node.

Then, then patients will perform their chemotherapy. The choice of NAC regimen is let at the discretion of each participating team.

After NAC, breast tumor size and axillary assessment are performed.

Breast and axillary surgery are performed during the same procedure, 4 to 6 weeks after completion of NAC. Breast surgery can be conservative or radical.

All patients undergo the resection of the tagged axillary node, SLN biopsy and a complementary axillary lymphadenectomy.

Phase : NA

Stade : Localisé à Localement avancé

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 1. Patients ≥ 18 years old
2. Initial diagnosis of operable invasive breast carcinoma
3. Histologically proven axillary metastasis (cytology or biopsy) before NAC
4. Patient included in a therapeutic approach of neoadjuvant chemotherapy
5. Procedure for the detection of sentinel lymph node by isotopic method +/-
6. Information of the patient and obtaining written consent, signed by the patient investigator
7. Affiliated patient or beneficiary of the social security

Critères de non-inclusion : 1. pT4d (inflammatory breast cancer)
2. Metastatic breast cancer
3. Any prior chemotherapy for contralateral breast cancer
4. Local relapse of breast cancer
5. Axillary metastasis not histologically proven before NAC
6. Allergy known to the 2 detection products (Blue and radioactive tracer)
7. Pregnant or lactating woman
8. Neo Adjuvant chemotherapy contraindicated
9. Patient protected or under guardianship or unable to give consent
10. Impossibility of submitting to the medical examination for geographical, social psychological
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03630913
Promoteur :
INSTITUT DE CANCEROLOGIE DE L'OUEST
Type de sponsor : Institutionnel
INSTITUT DE CANCEROLOGIE DE L'OUEST
44000 NANTES

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Marie-Pierre CHAUVET

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Ouverture de l'essai : OUVERT

MAJ : 27/01/2020