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NCT00210236 Clinical Trial

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

Breast Cancer Clinical Trial

— AXIL95  

Official title:
Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00210236
Other study ID # IB1995-28
Secondary ID Axil 95
Status Terminated
Phase Phase 3
First received September 12, 2005
Last updated July 25, 2013
Start date September 1995
Est. completion date December 2005

Study information
Verified date October 2007
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 592
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Conventional surgery

Locations
Country Name City State
France Centre Hospitalier Universitaire d'Agen Agen
France Centre Régional de Lutte Contre le Cancer d'Anger Angers
France Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest Bordeaux
France Centre Régional de Luttre Contre le Cancer de Clermont Ferrand Clermont Ferrand
France Centre Régional de Luttre Contre le Cancer de Dijon Dijon
France Centre Régional de Luttre Contre le Cancer de Lille Lille
France Centre Régional de Lutte Contre le Cancer de Lyon Lyon
France Centre Hospitalier Intercommunal de Marmande Marmande
France Centre Régional de Luttre Contre le Cancer de Montpellier Montpellier
France Clinique de la Source Orléans
France Centre Régional de Luttre Contre le Cancer de Nantes Saint Herblain
France Centre Hospitalier Universitaire de Saint Nazaire Saint Nazaire
France Centre Régional de Luttre Contre le Cancer de Strasbourg Strasbourg
France Centre Regional de Lutte Contre le Cancer de Toulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival (5 years)
Secondary Axillary recurrence (5 years)
Secondary Cancer Survival (5 years)
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