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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by Centre René Gauducheau
Sponsor:
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01221688
First received: October 11, 2010
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

GANEA 2 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 : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes. Patients of group 1, the study group, 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 Intervention
Breast Cancer
Procedure: Axillar Sentinel lymph node biopsy
Procedure: SLNB and complete level I-II axillary lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

Resource links provided by NLM:


Further study details as provided by Centre René Gauducheau:

Primary Outcome Measures:
  • false-negative rate for the Sentinel Lymph Node Detection [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 858
Study Start Date: July 2010
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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
group 1 : patients with proven involved axillary nodes will undergo SLNB 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T2-T3 operable infiltrating breast carcinoma
  • No allergy to Patent Blue
  • Pre-operative diagnosis of unilateral 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221688

Locations
France
Centre Paul Papin Recruiting
Angers, France, 49000
Contact: Gérard Lorimier, MD       g.lorimier@unimedia.fr   
Principal Investigator: Gérard Lorimier, MD         
CHU Recruiting
Angers, France, 49 000
Contact: Philippe Descamps, MD       phdescamps@chu-angers.fr   
Principal Investigator: Philippe Descamps, MD         
Institut Bergonié Recruiting
Bordeaux, France, 33000
Contact: Christine Tunon de Lara, MD       Tunon@bergonie.org   
Principal Investigator: Christine Tunon de Lara, MD         
CHU Recruiting
Brest, France, 29609
Contact: Pierre François Dupré, MD       pierre-francois.dupre@chu-brest.fr   
Principal Investigator: Pierre François Dupré, MD         
Centre Jean Perrin Recruiting
Clermont Ferrand, France
Contact: Pierre Guimbergues, MD       Pierre.GIMBERGUES@cjp.fr   
Principal Investigator: Pierre Guimbergues, MD         
Centre Hospitalier Recruiting
La Roche/yon, France
Contact: Carole Damey, MD       carole.damey@chd-vendee.fr   
Principal Investigator: carole Damey, MD         
Centre Oscar Lambret Recruiting
Lille, France, 59000
Contact: Sylvia Giard, MD       s-giard@o-lambret.fr   
Principal Investigator: Sylvia Giard, MD         
Hôpital E. Herriot Recruiting
Lyon, France, 69000
Contact: Patrice Mathevet, MD       patrice.mathevet@chu-lyon.fr   
Principal Investigator: Patrice Mathevet, MD         
Centre Léon Berard Recruiting
Lyon, France, 69 000
Contact: Christelle Faure, MD       faure@lyon.fnclcc.fr   
Principal Investigator: Faure-Virelizier, MD         
Institut Paoli Calmette Recruiting
Marseille, France, 13009
Contact: Gilles Houvenaeghel, MD       houvenag@marseille.fnclcc.fr   
Principal Investigator: Gilles Houvenaeghel, MD         
Centre Val d'aurelle Recruiting
Montpellier, France, 34298
Contact: Philippe Rouanet, MD       Prouanet@valdorel.fnclcc.fr   
Principal Investigator: Philippe Rouanet, MD         
Centre Alexis Vautrin Recruiting
Nancy, France, 54511
Contact: Frederic Marchal, MD       f.marchal@nancy.fnclcc.fr   
Principal Investigator: Frederic Marchal, MD         
CHU Brabois Active, not recruiting
Nancy, France, 54000
CHU Recruiting
Nantes, France, 44000
Contact: Eric Darnis, MD       Eric.darnis@chu-nantes.fr   
Principal Investigator: Eric Darnis, MD         
Hôpital Lariboisière Recruiting
Paris, France, 75000
Contact: Emmanuel Barrarger, MD       emmanuel.barranger@lrb.fr   
Principal Investigator: Emmanuel Barranger, MD         
Hôpital Saint Louis Active, not recruiting
Paris, France, 75000
Hôpital Européen Georges Pompidou Recruiting
Paris, France, 75000
Contact: Fabrice Lecuru, MD       fabrice.lecuru@egp.aphp.fr   
Principal Investigator: Fabrice Lecuru, MD         
Hôpital Tenon Recruiting
Paris, France, 75000
Contact: Roman Rouzier, MD       roman.rouzier@tnn.aphp.fr   
Principal Investigator: Roman Rouzier, MD         
Institut Curie Recruiting
Paris, France, 75 000
Contact: Servine Alran, MD       severine.alran@curie.net   
Principal Investigator: Severine Alran, MD         
Clinique Lasagesse Not yet recruiting
Rennes, France, 35000
Contact: Jérôme Blanchot, MD       jblanchot@lasagesse.fr   
Principal Investigator: Jérôme Blanchot, MD         
Centre Eugène Marquis Not yet recruiting
Rennes, France, 35511
Contact: Jean Levêque, MD       jean.leveque@chu-rennes.fr   
Principal Investigator: Jean Levêque, MD         
Centgre René Becquerel Recruiting
Rouen, France
Contact: Marc Baron, MD       Marc.baron@rouen.fnclcc.fr   
Principal Investigator: Marc Baron, MD         
Centre René Huguenin Recruiting
Saint Cloud, France, 92210
Contact: Catherine Bellichard, MD       c.belichard@stcloud-huguenin.org   
Principal Investigator: Catherine Bellichard, MD         
Centre René Gauducheau Recruiting
Saint Herblain, France, 44805
Contact: Jean Marc Classe, MD    +33240679900      
Principal Investigator: Jean Marc Classe, MD         
Institut Gustave Roussy Not yet recruiting
Villejuif, France
Contact: Jean Remy Garbay, MD       jean-remi.garbay@igr.fr   
Principal Investigator: Jean Remi Garbay, MD         
Sponsors and Collaborators
Centre René Gauducheau
  More Information

No publications provided

Responsible Party: Mme Scotet-Cérato, Centre René Gauducheau
ClinicalTrials.gov Identifier: NCT01221688     History of Changes
Other Study ID Numbers: BRD 09/9-G
Study First Received: October 11, 2010
Last Updated: October 14, 2010
Health Authority: France : Afssaps

Keywords provided by Centre René Gauducheau:
Sentinel lymph node biopsy (SLNB)
large operable breast cancer
neoadjuvant chemotherapy
patients with large operable breast cancer after neoadjuvant chemotherapy (NAC)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014