Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: SLNB and complete level I-II axillary lymphadenectomy; Procedure: Axillar Sentinel lymph node biopsy

• Registration Number: NCT01221688
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-12
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Primary Completion: 2014-10-27
• Study Completion: 2019-12-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 958

Inclusion Criteria

• T2-T3 operable infiltrating breast carcinoma
• No allergy to Patent Blue
• Pre-operative diagnosis of unifocal infiltrating breast carcinoma.
• Patient planned to be treated by NAC.
• Informed consent.
• Surgery available 4 to 6 weeks after the last chemotherapy course (radical or conservative surgery)

Exclusion Criteria

• pT4d (inflammatory breast cancer)
• Locally advanced or metastatic breast cancer
• Any previous chemotherapy of contra-lateral breast cancer.
• Breast cancer local relapse
• Previous surgical removal of breast Cancer.
• Inadequate biopsy for pathological analysis.
• Dementia or altered mental disorder
• Pregnant woman or breast feeding or without efficacious contraceptive method.
• Contra-indication to NAC NAC interrupted due to progressive disease.
• Neoadjuvant radiotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1 (pN+)	SLNB and complete level I-II axillary lymphadenectomy	group 1 : patients with proven involved axillary nodes will undergo SLN biopsy and complete level I-II axillary lymphadenectomy.
group 2 (cN0)	Axillar Sentinel lymph node biopsy	Patients without proven axillary involved nodes will undergo SLN biopsy and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLN biopsy 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.

Primary Outcome Measures

Name	Time	Method
false-negative (FN) rate for the Sentinel Lymph Node Detection	after surgery	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

Secondary Outcome Measures

Name	Time	Method
Sataloff score on breast tumour	after surgery	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
Sataloff score on lymph nodes	after surgery	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.
Homolateral axillary recurrence rate	5 years post surgery	Recurrence observed groupe 2 patients (cN0) whitout ALND
Detection rate	after surgery	Percentage of patients with SLN detected and isolated intraoperatively

Trial Locations

Locations (16)

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

ICANS; 🇫🇷 Strasbourg, France

HEGP; 🇫🇷 Paris, France

Institut de Cancerologie de L'Ouest; 🇫🇷 Angers, France

Centre Léon Berard; 🇫🇷 Lyon, France

CHU; 🇫🇷 Brest, France

Centre Oscar Lambret; 🇫🇷 Lille, France

INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle; 🇫🇷 Montpellier, France

CH; 🇫🇷 La Roche-sur-Yon, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Institut de Cancérlogie de Lorraine; 🇫🇷 Nancy, France

Institut Curie; 🇫🇷 Saint-Cloud, France

Institut de cancérologie de l'Ouest; 🇫🇷 Saint Herblain, France

Hôpital Lariboisière; 🇫🇷 Paris, France