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

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ClinicalTrials.gov Identifier: NCT00210236
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : July 26, 2013
Information provided by:
Institut Bergonié

September 12, 2005
September 21, 2005
July 26, 2013
September 1995
Not Provided
Overall Survival (5 years)
Same as current
Complete list of historical versions of study NCT00210236 on ClinicalTrials.gov Archive Site
  • Axillary recurrence (5 years)
  • Cancer Survival (5 years)
Same as current
Not Provided
Not Provided
Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer
Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm
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
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Procedure: Conventional surgery
Not Provided
Avril A, Le Bouëdec G, Lorimier G, Classe JM, Tunon-de-Lara C, Giard S, MacGrogan G, Debled M, Mathoulin-Pélissier 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2005
Not Provided

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

Sexes Eligible for Study: Female
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Axil 95
Not Provided
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Not Provided
Institut Bergonié
Not Provided
Principal Investigator: Antoine AVRIL, MD Institut Bergonié
Institut Bergonié
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP