Breast CancerPhase 3AXIL95NCT00210236
Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer
A Phase 3 study testing Conventional surgery WITHOUT Axillary Lymph Node Excision and Conventional surgery WITH Axillary Lymph Node Excision in people with Breast Cancer, run by Institut Bergonié at 14 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Conventional surgery WITHOUT Axillary Lymph Node Excision and Conventional surgery WITH Axillary Lymph Node Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 14 sitesFrance
- Study dates
- Sep 1995to Dec 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Previous cancer history life expectancy < 10 years Metastasis
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Centre Hospitalier Universitaire d'Agen
Agen, 47000
Centre Régional de Lutte Contre le Cancer d'Anger
Angers, 49000
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076
Centre Régional de Luttre Contre le Cancer de Clermont Ferrand
Clermont-Ferrand, 63000
Centre Régional de Luttre Contre le Cancer de Dijon
Dijon, 21000
Centre Régional de Luttre Contre le Cancer de Lille
Lille, 59000
Centre Régional de Lutte Contre le Cancer de Lyon
Lyon, 69000
Centre Hospitalier Intercommunal de Marmande
Marmande, 47200
Centre Régional de Luttre Contre le Cancer de Montpellier
Montpellier, 34000
Clinique de la Source
Orléans, 45000
Centre Régional de Luttre Contre le Cancer de Nantes
Saint-Herblain, 44800
Centre Hospitalier Universitaire de Saint Nazaire
Saint-Nazaire, 44600
Centre Régional de Luttre Contre le Cancer de Strasbourg
Strasbourg, 67000
Centre Regional de Lutte Contre le Cancer de Toulouse
Toulouse, 31000
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Conventional surgery WITHOUT Axillary Lymph Node Excision, Conventional surgery WITH Axillary Lymph Node Excision
- Keywords
- Breast neoplasms, Local recurrence, Survival, Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional surgery WITHOUT Axillary Lymph Node ExcisionProcedure or surgery
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Conventional surgery WITH Axillary Lymph Node ExcisionProcedure or surgery
Also called Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery WITH Axillary Lymph Node Excision | Experimental | Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Receives: Procedure: Conventional surgery WITH Axillary Lymph Node Excision |
| Conventional surgery WITHOUT Axillary Lymph Node Excision | Active comparator | Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Receives: Procedure: Conventional surgery WITHOUT Axillary Lymph Node Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Deaths
Measured: Five years after surgery
Secondary outcomes (1)
Rate of Axillary Recurrence
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.
Measured: Five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 1995
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine AVRIL, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210236
- Sponsor's protocol ID
- IB1995-28
- Acronym
- AXIL95
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2005
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
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.
PubMed 21665421
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm
- ClinicalTrials.gov ID
- NCT00210236
- Acronym / sponsor ID
- AXIL95 / IB1995-28
- Conditions
- Breast Cancer
- Keywords
- Breast neoplasms, Local recurrence, Survival, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Sep 1995 (actual)
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery WITH Axillary Lymph Node Excision | Experimental | Procedure: Conventional surgery WITH Axillary Lymph Node ExcisionTumorectomy or mastectomy, WITH Axillary Lymph Node Excision |
| Conventional surgery WITHOUT Axillary Lymph Node Excision | Active comparator | Procedure: Conventional surgery WITHOUT Axillary Lymph Node ExcisionTumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Previous cancer history life expectancy < 10 years Metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional surgery WITHOUT Axillary Lymph Node ExcisionTumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision | Procedure or surgery | Conventional surgery WITHOUT Axillary Lymph Node Excision |
| Conventional surgery WITH Axillary Lymph Node ExcisionAlso: Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision | Procedure or surgery | Conventional surgery WITH Axillary Lymph Node Excision |
Primary outcome
Number of Deaths
Time frame: Five years after surgery
1 secondary outcome
Rate of Axillary Recurrence
Time frame: Five years after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21665421Avril 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine AVRIL, MD principal investigator
Institut Bergonié
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional surgery WITHOUT Axillary Lymph Node Excision and Conventional surgery WITH Axillary Lymph Node Excision in people with Breast Cancer, run by Institut Bergonié at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Deaths (time frame: Five years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.