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Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer (AXIL95)

This study has been terminated.
Sponsor:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210236
First received: September 12, 2005
Last updated: December 29, 2011
Last verified: October 2007
History of Changes
  Purpose

This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic axillary node clearance can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50


Condition Intervention Phase
Breast Cancer
 Procedure: Conventional surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Overall Survival (5 years)

Secondary Outcome Measures:
  • Axillary recurrence (5 years)
  • Cancer Survival (5 years)

Estimated Enrollment: 1612
Study Start Date: September 1995
Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Women, 50 year or more Menopausal women Breast cancer Macroscopic tumor size of 10 mm or less (measured during operation) No palpable axillary node ( N0)

Exclusion criteria:

Previous cancer history life expectancy < 10 years Metastasis

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210236

Locations
France
Centre Hospitalier Universitaire d'Agen
Agen, France, 47000
Centre Régional de Lutte Contre le Cancer d'Anger
Angers, France, 49000
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Centre Régional de Luttre Contre le Cancer de Clermont Ferrand
Clermont Ferrand, France, 63000
Centre Régional de Luttre Contre le Cancer de Dijon
Dijon, France, 21000
Centre Régional de Luttre Contre le Cancer de Lille
Lille, France, 59000
Centre Régional de Lutte Contre le Cancer de Lyon
Lyon, France, 69000
Centre Hospitalier Intercommunal de Marmande
Marmande, France, 47200
Centre Régional de Luttre Contre le Cancer de Montpellier
Montpellier, France, 34000
Clinique de la Source
Orléans, France, 45000
Centre Régional de Luttre Contre le Cancer de Nantes
Saint Herblain, France, 44800
Centre Hospitalier Universitaire de Saint Nazaire
Saint Nazaire, France, 44600
Centre Régional de Luttre Contre le Cancer de Strasbourg
Strasbourg, France, 67000
Centre Regional de Lutte Contre le Cancer de Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Antoine AVRIL, MD Institut Bergonié
  More Information

No publications provided by Institut Bergonié

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00210236     History of Changes
Other Study ID Numbers: IB1995-28, Axil 95
Study First Received: September 12, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Breast neoplasms
Local recurrence
Survival
Surgery

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

ClinicalTrials.gov processed this record on June 17, 2013