Clinical trial NCT00210236: Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast neoplasms
Local recurrence
Survival
Surgery
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 592
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Overall Survival (5 years)
Secondary outcomes:
measure: Axillary recurrence (5 years)
measure: Cancer Survival (5 years)
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre Hospitalier Universitaire d'Agen
city: Angers
country: France
facility: Centre Régional de Lutte Contre le Cancer d'Anger
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
city: Clermont Ferrand
country: France
facility: Centre Régional de Luttre Contre le Cancer de Clermont Ferrand
city: Dijon
country: France
facility: Centre Régional de Luttre Contre le Cancer de Dijon
city: Lille
country: France
facility: Centre Régional de Luttre Contre le Cancer de Lille
city: Lyon
country: France
facility: Centre Régional de Lutte Contre le Cancer de Lyon
city: Marmande
country: France
facility: Centre Hospitalier Intercommunal de Marmande
city: Montpellier
country: France
facility: Centre Régional de Luttre Contre le Cancer de Montpellier
city: Orléans
country: France
facility: Clinique de la Source
city: Saint Herblain
country: France
facility: Centre Régional de Luttre Contre le Cancer de Nantes
city: Saint Nazaire
country: France
facility: Centre Hospitalier Universitaire de Saint Nazaire
city: Strasbourg
country: France
facility: Centre Régional de Luttre Contre le Cancer de Strasbourg
city: Toulouse
country: France
facility: Centre Regional de Lutte Contre le Cancer de Toulouse
Study officials:
affiliation: Institut Bergonié
name: Antoine AVRIL, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.