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

NCT ID: NCT00210236

Last Updated: 2025-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

625 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-09-30

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional surgery WITH Axillary Lymph Node Excision

Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision

Group Type EXPERIMENTAL

Conventional surgery WITH Axillary Lymph Node Excision

Intervention Type PROCEDURE

Conventional surgery WITHOUT Axillary Lymph Node Excision

Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision

Group Type ACTIVE_COMPARATOR

Conventional surgery WITHOUT Axillary Lymph Node Excision

Intervention Type PROCEDURE

Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional surgery WITHOUT Axillary Lymph Node Excision

Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision

Intervention Type PROCEDURE

Conventional surgery WITH Axillary Lymph Node Excision

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoine AVRIL, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Universitaire d'Agen

Agen, , France

Site Status

Centre Régional de Lutte Contre le Cancer d'Anger

Angers, , France

Site Status

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

Bordeaux, , France

Site Status

Centre Régional de Luttre Contre le Cancer de Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Centre Régional de Luttre Contre le Cancer de Dijon

Dijon, , France

Site Status

Centre Régional de Luttre Contre le Cancer de Lille

Lille, , France

Site Status

Centre Régional de Lutte Contre le Cancer de Lyon

Lyon, , France

Site Status

Centre Hospitalier Intercommunal de Marmande

Marmande, , France

Site Status

Centre Régional de Luttre Contre le Cancer de Montpellier

Montpellier, , France

Site Status

Clinique de la Source

Orléans, , France

Site Status

Centre Régional de Luttre Contre le Cancer de Nantes

Saint-Herblain, , France

Site Status

Centre Hospitalier Universitaire de Saint Nazaire

Saint-Nazaire, , France

Site Status

Centre Régional de Luttre Contre le Cancer de Strasbourg

Strasbourg, , France

Site Status

Centre Regional de Lutte Contre le Cancer de Toulouse

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Avril A, Le Bouedec G, Lorimier G, Classe JM, Tunon-de-Lara C, Giard S, MacGrogan G, Debled M, Mathoulin-Pelissier 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.

Reference Type DERIVED
PMID: 21665421 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IB1995-28

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.