Status:

TERMINATED

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

Lead Sponsor:

Institut Bergonié

Conditions:

Breast Cancer

Eligibility:

FEMALE

50-100 years

Phase:

PHASE3

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 brea...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 1995

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2005

    Estimated Enrollment :

    625 Patients enrolled

    Trial Details

    Trial ID

    NCT00210236

    Start Date

    September 1 1995

    End Date

    December 1 2005

    Last Update

    October 17 2025

    Active Locations (14)

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    Page 1 of 4 (14 locations)

    1

    Centre Hospitalier Universitaire d'Agen

    Agen, France, 47000

    2

    Centre Régional de Lutte Contre le Cancer d'Anger

    Angers, France, 49000

    3

    Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

    Bordeaux, France, 33076

    4

    Centre Régional de Luttre Contre le Cancer de Clermont Ferrand

    Clermont-Ferrand, France, 63000