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

NCT ID: NCT01221688

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 958 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-12
• Study Completion Date: 2019-12-10

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

group 2 (cN0)

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.

Group Type: OTHER

Axillar Sentinel lymph node biopsy

Intervention Type: PROCEDURE

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 (pN+)

group 1 : patients with proven involved axillary nodes will undergo SLN biopsy and complete level I-II axillary lymphadenectomy.

Group Type: EXPERIMENTAL

SLNB and complete level I-II axillary lymphadenectomy

Intervention Type: PROCEDURE

group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.

Interventions

Axillar Sentinel lymph node biopsy

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.

Intervention Type: PROCEDURE

SLNB and complete level I-II axillary lymphadenectomy

group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc CLASSE, MD

Role: PRINCIPAL_INVESTIGATOR

INSTITUT DE CANCEROLOGIE DE L'OUEST

Locations

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

Institut de Cancérlogie de Lorraine

Nancy, , France

Institut Curie

Paris, , France

Hôpital Européen Georges Pompidou

Paris, , France

Hôpital Lariboisière

Paris, , France

HEGP

Paris, , France

Institut Curie

Saint-Cloud, , France

Institut de cancérologie de l'Ouest

Saint-Herblain, , France

ICANS

Strasbourg, , France

Countries

France

Other Identifiers

BRD 09/9-G

Identifier Type: -

Identifier Source: org_study_id