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

Breast Cancer Clinical Trial

— GANEA2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221688
• Other study ID #: BRD 09/9-G
• Status: Completed
• Phase: N/A
• Start date: July 12, 2010
• Est. completion date: December 10, 2019

Study information

• Verified date: April 2022
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 958
• Est. completion date: December 10, 2019
• Est. primary completion date: October 27, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	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	HEGP	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Lariboisière	Paris
France	Institut Curie	Paris
France	Institut de cancérologie de l'Ouest	Saint Herblain
France	Institut Curie	Saint-Cloud
France	ICANS	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	false-negative (FN) rate for the Sentinel Lymph Node Detection	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	after surgery
Secondary	Detection rate	Percentage of patients with SLN detected and isolated intraoperatively	after surgery
Secondary	Sataloff score on breast tumour	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	after surgery
Secondary	Sataloff score on lymph nodes	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.	after surgery
Secondary	Homolateral axillary recurrence rate	Recurrence observed groupe 2 patients (cN0) whitout ALND	5 years post surgery