Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer (GANEA2)

Institut Cancerologie de l'Ouest

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: SLNB and complete level I-II axillary lymphadenectomy; Procedure: Axillar Sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01221688

BRD 09/9-G

Details and patient eligibility

About

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.

Enrollment: 958 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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958 participants in 2 patient groups

group 2 (cN0)

Other group

Description:

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.

Treatment:

Procedure: Axillar Sentinel lymph node biopsy

group 1 (pN+)

Experimental group

Description:

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

Treatment:

Procedure: SLNB and complete level I-II axillary lymphadenectomy