NCT01221688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
958

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2014

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

October 11, 2010

Last Update Submit

April 19, 2022

Conditions

Breast Cancer

Keywords

Breast cancerneoadjuvant chemotherapyFalse negative rateAxillary lymph node dissectionSentinel lymph node

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Detection rate

    after surgery

  • Sataloff score on breast tumour

    after surgery

  • Sataloff score on lymph nodes

    after surgery

  • Homolateral axillary recurrence rate

    5 years post surgery

Study Arms (2)

group 2 (cN0)

OTHER

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 1 (pN+)

EXPERIMENTAL

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

Interventions

Axillar Sentinel lymph node biopsyPROCEDURE

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 2 (cN0)
SLNB and complete level I-II axillary lymphadenectomyPROCEDURE

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

group 1 (pN+)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU

Angers, 49 933, France

Location

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Location

Institut Bergonié

Bordeaux, 33000, France

Location

CHU

Brest, 29609, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

CH

La Roche-sur-Yon, 85925, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Léon Berard

Lyon, 69 000, France

Location

Institut Paoli Calmette

Marseille, 13009, France

Location

INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle

Montpellier, 34298, France

Location

Institut de Cancérlogie de Lorraine

Nancy, 54511, France

Location

Institut Curie

Paris, 75 000, France

Location

Hôpital Européen Georges Pompidou

Paris, 75000, France

Location

Hôpital Lariboisière

Paris, 75000, France

Location

HEGP

Paris, 75908, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Institut de cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

ICANS

Strasbourg, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-Marc CLASSE, MD

    INSTITUT DE CANCEROLOGIE DE L'OUEST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 15, 2010

Study Start

July 12, 2010

Primary Completion

October 27, 2014

Study Completion

December 10, 2019

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

FR(18)