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Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer (GANEA 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT01221688
First received: October 11, 2010
Last updated: August 30, 2016
Last verified: August 2016
  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 Institut Cancerologie de l'Ouest:

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 Study Completion Date: July 2019
Primary Completion Date: July 2015 (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   (Adult, Senior)
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
CHU
Angers, France, 49 000
Centre Paul Papin
Angers, France, 49000
Institut Bergonié
Bordeaux, France, 33000
CHU
Brest, France, 29609
Centre Jean Perrin
Clermont Ferrand, France
Centre Hospitalier
La Roche/yon, France
Centre Oscar Lambret
Lille, France, 59000
Centre Léon Berard
Lyon, France, 69 000
Hôpital E. Herriot
Lyon, France, 69000
Institut Paoli Calmette
Marseille, France, 13009
Centre Val d'aurelle
Montpellier, France, 34298
CHU Brabois
Nancy, France, 54000
Centre Alexis Vautrin
Nancy, France, 54511
CHU
Nantes, France, 44000
Institut Curie
Paris, France, 75 000
Hôpital Européen Georges Pompidou
Paris, France, 75000
Hôpital Lariboisière
Paris, France, 75000
Hôpital Saint Louis
Paris, France, 75000
Hôpital Tenon
Paris, France, 75000
Clinique Lasagesse
Rennes, France, 35000
Centre Eugène Marquis
Rennes, France, 35511
Centgre René Becquerel
Rouen, France
Centre René Huguenin
Saint Cloud, France, 92210
Centre René Gauducheau
Saint Herblain, France, 44805
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
  More Information

Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT01221688     History of Changes
Other Study ID Numbers: BRD 09/9-G 
Study First Received: October 11, 2010
Last Updated: August 30, 2016
Health Authority: France : Afssaps

Keywords provided by Institut Cancerologie de l'Ouest:
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 September 23, 2016