Clinical trial · Interventional
Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
NCT01508546CI-TRIAL-00006048completedPhase 3ClinicalTrials.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)
Rationale Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning. Purpose Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer. To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Ductal, Breast | Breast Ductal Carcinoma | ALIAS | 0.90 |
| Female Breast Neoplasms | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axillary dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: breast surgery with axillary lymphnodes removal
- interventionNames
- Procedure: axillary dissection
- type
- EXPERIMENTAL
- label
- Arm 2: breast surgery without axillary lymphnodes removal
- interventionNames
- Procedure: axillary dissection
Primary outcomes (1)
- measure
- Difference in breast cancer mortality and overall survival between the two arms
- timeFrame
- median follow-up time: 10 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * women with T1N0M0 invasive breast cancer * 18-65 years Exclusion Criteria: * bilateral breast cancer * no other prior or concurrent malignancy except basal cell carcinoma
References
Publications (1)
- DERIVEDAgresti R, Sandri M, Capri G, Bianchi G, Triulzi T, Lozza L, Trecate G, Trapani A, Ferraris C, Paolini B, Menard S, Greco M, Folli S, Tagliabue E. Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial. Br J Surg. 2025 Mar 4;112(3):znae311. doi: 10.1093/bjs/znae311. PMID 40042985