Clinical trial · Interventional
Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer
Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm
NCT00210236CI-TRIAL-00096657AXIL95terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional surgery WITH Axillary Lymph Node Excision | Procedure | — | UNRESOLVED |
| Conventional surgery WITHOUT Axillary Lymph Node Excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conventional surgery WITH Axillary Lymph Node Excision
- description
- Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
- interventionNames
- Procedure: Conventional surgery WITH Axillary Lymph Node Excision
- type
- ACTIVE_COMPARATOR
- label
- Conventional surgery WITHOUT Axillary Lymph Node Excision
- description
- Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
- interventionNames
- Procedure: Conventional surgery WITHOUT Axillary Lymph Node Excision
Primary outcomes (1)
- measure
- Number of Deaths
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAvril 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. PMID 21665421