NCT01221688

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 958 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2010-07-12
• Primary completion: 2014-10-27
• Completion: 2019-12-10
• First posted: 2010-10-15
• Last updated: 2022-04-25

Locations

18 sites across 1 country: France