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

September 30, 2025 updated by: Institut Bergonié

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 Lymph Node Excision can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

625

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47000
        • Centre Hospitalier Universitaire d'Agen
      • Angers, France, 49000
        • Centre Régional de Lutte Contre le Cancer d'Anger
      • Bordeaux, France, 33076
        • Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
      • Clermont-Ferrand, France, 63000
        • Centre Régional de Luttre Contre le Cancer de Clermont Ferrand
      • Dijon, France, 21000
        • Centre Régional de Luttre Contre le Cancer de Dijon
      • Lille, France, 59000
        • Centre Régional de Luttre Contre le Cancer de Lille
      • Lyon, France, 69000
        • Centre Régional de Lutte Contre le Cancer de Lyon
      • Marmande, France, 47200
        • Centre Hospitalier Intercommunal de Marmande
      • Montpellier, France, 34000
        • Centre Régional de Luttre Contre le Cancer de Montpellier
      • Orléans, France, 45000
        • Clinique de la Source
      • Saint-Herblain, France, 44800
        • Centre Régional de Luttre Contre le Cancer de Nantes
      • Saint-Nazaire, France, 44600
        • Centre Hospitalier Universitaire de Saint Nazaire
      • Strasbourg, France, 67000
        • Centre Régional de Luttre Contre le Cancer de Strasbourg
      • Toulouse, France, 31000
        • Centre Regional de Lutte Contre le Cancer de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional surgery WITH Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
Procedure: Conventional surgery WITH Axillary Lymph Node Excision
Other Names:
  • Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
Active Comparator: Conventional surgery WITHOUT Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Procedure: Conventional surgery WITHOUT Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Deaths
Time Frame: Five years after surgery
Five years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Axillary Recurrence
Time Frame: 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.
Five years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Principal Investigator: Antoine AVRIL, MD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 1995

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

October 20, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB1995-28
  • Axil 95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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