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

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Completed

CT.gov ID

NCT01221688

Collaborator

(none)

958

Enrollment

Locations

Arms

113

Actual Duration (Months)

53.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Axillar Sentinel lymph node biopsy Procedure: SLNB and complete level I-II axillary lymphadenectomy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

958 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Early breast cancer patients treated with neo-adjuvant chemotherapy (NAC) were included. Before NAC, patients with cytologically proven node involvement were allocated into the pN1 group, other patient were allocated into the cN0 group. After NAC, pN1 group patients underwent sentinel lymph node (SLN) and axillary lymph node dissection (ALND); cN0 group patients underwent SLN and ALND only in case of mapping failure or SLN involvement.Early breast cancer patients treated with neo-adjuvant chemotherapy (NAC) were included. Before NAC, patients with cytologically proven node involvement were allocated into the pN1 group, other patient were allocated into the cN0 group. After NAC, pN1 group patients underwent sentinel lymph node (SLN) and axillary lymph node dissection (ALND); cN0 group patients underwent SLN and ALND only in case of mapping failure or SLN involvement.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 12, 2010

Actual Primary Completion Date :

Oct 27, 2014

Actual Study Completion Date :

Dec 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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.
Experimental: group 1 (pN+) group 1 : patients with proven involved axillary nodes will undergo SLN biopsy and complete level I-II axillary 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.

Arm

Intervention/Treatment

Other: 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.

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.

Experimental: group 1 (pN+)

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

Outcome Measures

Primary Outcome Measures

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

Detection rate [after surgery]
Percentage of patients with SLN detected and isolated intraoperatively
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU	Angers	France	49 933
2	Institut de Cancerologie de L'Ouest	Angers	France	49055
3	Institut Bergonié	Bordeaux	France	33000
4	CHU	Brest	France	29609
5	Centre Jean Perrin	Clermont Ferrand	France
6	CH	La Roche-sur-Yon	France	85925
7	Centre Oscar Lambret	Lille	France	59000
8	Centre Léon Berard	Lyon	France	69 000
9	Institut Paoli Calmette	Marseille	France	13009
10	INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle	Montpellier	France	34298
11	Institut de Cancérlogie de Lorraine	Nancy	France	54511
12	Institut Curie	Paris	France	75 000
13	Hôpital Européen Georges Pompidou	Paris	France	75000
14	Hôpital Lariboisière	Paris	France	75000
15	HEGP	Paris	France	75908
16	Institut de cancérologie de l'Ouest	Saint Herblain	France	44805
17	Institut Curie	Saint-Cloud	France	92210
18	ICANS	Strasbourg	France