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

April 19, 2022 updated by: Institut Cancerologie de l'Ouest

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

958

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49055
        • Institut de Cancérologie de l'Ouest
      • Angers, France, 49 933
        • CHU
      • Bordeaux, France, 33000
        • Institut Bergonie
      • Brest, France, 29609
        • CHU
      • Clermont Ferrand, France
        • Centre Jean PERRIN
      • La Roche-sur-Yon, France, 85925
        • CH
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lyon, France, 69 000
        • Centre Leon Berard
      • Marseille, France, 13009
        • Institut Paoli Calmette
      • Montpellier, France, 34298
        • Institut de Cancérologie de Montpellier Val d'Aurelle
      • Nancy, France, 54511
        • Institut de Cancérlogie de Lorraine
      • Paris, France, 75908
        • HEGP
      • Paris, France, 75000
        • Hopital Lariboisiere
      • Paris, France, 75000
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75 000
        • Institut Curie
      • Saint Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest
      • Saint-Cloud, France, 92210
        • Institut Curie
      • Strasbourg, France
        • ICANS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
false-negative (FN) rate for the Sentinel Lymph Node Detection
Time Frame: 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
after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate
Time Frame: after surgery
Percentage of patients with SLN detected and isolated intraoperatively
after surgery
Sataloff score on breast tumour
Time Frame: 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
after surgery
Sataloff score on lymph nodes
Time Frame: 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.
after surgery
Homolateral axillary recurrence rate
Time Frame: 5 years post surgery
Recurrence observed groupe 2 patients (cN0) whitout ALND
5 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Jean-Marc CLASSE, MD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2010

Primary Completion (Actual)

October 27, 2014

Study Completion (Actual)

December 10, 2019

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD 09/9-G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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