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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Conventional surgery
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast neoplasms, Local recurrence, Survival, Surgery

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire d'Agen
  • Centre Régional de Lutte Contre le Cancer d'Anger
  • Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
  • Centre Régional de Luttre Contre le Cancer de Clermont Ferrand
  • Centre Régional de Luttre Contre le Cancer de Dijon
  • Centre Régional de Luttre Contre le Cancer de Lille
  • Centre Régional de Lutte Contre le Cancer de Lyon
  • Centre Hospitalier Intercommunal de Marmande
  • Centre Régional de Luttre Contre le Cancer de Montpellier
  • Clinique de la Source
  • Centre Régional de Luttre Contre le Cancer de Nantes
  • Centre Hospitalier Universitaire de Saint Nazaire
  • Centre Régional de Luttre Contre le Cancer de Strasbourg
  • Centre Regional de Lutte Contre le Cancer de Toulouse

Outcomes

Primary Outcome Measures

Overall Survival (5 years)

Secondary Outcome Measures

Axillary recurrence (5 years)
Cancer Survival (5 years)

Full Information

First Posted
September 12, 2005
Last Updated
July 25, 2013
Sponsor
Institut Bergonié
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1. Study Identification

Unique Protocol Identification Number
NCT00210236
Brief Title
Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer
Acronym
AXIL95
Official Title
Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Study Start Date
September 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Bergonié

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast neoplasms, Local recurrence, Survival, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
592 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Conventional surgery
Primary Outcome Measure Information:
Title
Overall Survival (5 years)
Secondary Outcome Measure Information:
Title
Axillary recurrence (5 years)
Title
Cancer Survival (5 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine AVRIL, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Agen
City
Agen
ZIP/Postal Code
47000
Country
France
Facility Name
Centre Régional de Lutte Contre le Cancer d'Anger
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Régional de Luttre Contre le Cancer de Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Régional de Luttre Contre le Cancer de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Régional de Luttre Contre le Cancer de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Régional de Lutte Contre le Cancer de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Centre Hospitalier Intercommunal de Marmande
City
Marmande
ZIP/Postal Code
47200
Country
France
Facility Name
Centre Régional de Luttre Contre le Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Clinique de la Source
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Centre Régional de Luttre Contre le Cancer de Nantes
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Centre Régional de Luttre Contre le Cancer de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21665421
Citation
Avril A, Le Bouedec G, Lorimier G, Classe JM, Tunon-de-Lara C, Giard S, MacGrogan G, Debled M, Mathoulin-Pelissier S, Mauriac L; AXIL95 Group. Phase III randomized equivalence trial of early breast cancer treatments with or without axillary clearance in post-menopausal patients results after 5 years of follow-up. Eur J Surg Oncol. 2011 Jul;37(7):563-70. doi: 10.1016/j.ejso.2011.04.008. Epub 2011 Jun 12.
Results Reference
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Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer

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