Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210236
First received: September 12, 2005
Last updated: July 25, 2013
Last verified: October 2007

September 12, 2005
July 25, 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Terminated
592
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

Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00210236
IB1995-28, Axil 95
Not Provided
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