Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer - Full Text View

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 III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Menopause

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

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
	Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
	Bordeaux, France, 33076
	Centre Hospitalier Intercommunal de Marmande
	MARMANDE, France, 47200
	Centre Hospitalier Universitaire de Saint Nazaire
	Saint Nazaire, France, 44600
	Centre Hospitalier Universitaire d'Agen
	AGEN, France, 47000
	Clinique de la Source
	Orléans, France, 45000
	Centre Régional de Lutte Contre le Cancer d'Anger
	Angers, France, 49000
	Centre Régional de Luttre Contre le Cancer de Clermont Ferrand
	Clermont Ferrand, France, 63000
	Centre Régional de Luttre Contre le Cancer de Nantes
	Saint Herblain, France, 44800
	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 Régional de Luttre Contre le Cancer de Strasbourg
	Strasbourg, France, 67000
	Centre Regional de Lutte Contre le Cancer de Toulouse
	Toulouse, France, 31000
	Centre Régional de Luttre Contre le Cancer de Montpellier
	Montpellier, France, 34000
	Centre Régional de Luttre Contre le Cancer de Dijon
	Dijon, France, 21000

Sponsors and Collaborators

Institut Bergonié

Investigators


Principal Investigator:	Antoine AVRIL, MD	Institut Bergonié

More Information

Study ID Numbers:	IB1995-28, Axil 95
First Received:	September 12, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00210236
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Bergonié:

Breast neoplasms

Local recurrence

Survival

Surgery

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Menopause

Breast Diseases

Recurrence

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Institut Bergonié
Information provided by:	Institut Bergonié
ClinicalTrials.gov Identifier:	NCT00210236