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

Phase 3

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00210236
• Lead Sponsor: Institut Bergonié

Brief Summary

This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic Axillary Lymph Node Excision can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50

Detailed Description

Phase III randomized multicenter equivalence trial evaluating the role of Axillary Lymph Node Excision.

Primary aim is to assess if it is possible to avoid routine Axillary Lymph Node Excision during the initial treatment of breast cancers smaller than 11 mm in women aged 50 and older without compromising survival? The primary endpoint is overall survival: the event considered will be death from any cause.

Study Timeline

• Study Start: 1995-09-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2005-12
• Study Completion: 2005-12-01
• Results First Submitted: 2025-08-22
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Results First Posted: 2025-10-20
• Last Update Posted: 2025-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 625

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Deaths	Five years after surgery

Secondary Outcome Measures

Name	Time	Method
Rate of Axillary Recurrence	Five years after surgery	Proportion of participants with axiallary recurrence. Axillary (Regional) recurrence is defined as tumor recurrence in lymph nodes draining the primary tumor site, namely, nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area.

Trial Locations

Locations (14)

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

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