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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:
ClinicalTrials.gov Identifier:
NCT00210236
First Posted: September 21, 2005
Last Update Posted: July 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut Bergonié
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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)

Enrollment: 592
Study Start Date: September 1995
Study Completion Date: December 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 12, 2005
First Posted: September 21, 2005
Last Update Posted: July 26, 2013
Last Verified: October 2007

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