Clinical trial · Interventional
GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer
A Randomized, Phase III Clinical Trial GF-GS 01 to Compare Conventional Axillary Dissection Versus Sentinel Node Resection (GS) in Clinically Node-negative Operable Breast Cancer Unifocal N0 Patients
NCT00144898CI-TRIAL-00038811completedPhase 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)
Sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer. The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new surgical method with a classical method in patients having a negative sentinel node. The duration of the follow-up is 5 years.
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 Axillary Dissection | Procedure | — | UNRESOLVED |
| Sentinel Node Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sentinel Node Resection
- description
- Sentinel Node Resection
- interventionNames
- Procedure: Sentinel Node Resection
- type
- OTHER
- label
- Conventional Axillary Dissection
- description
- Conventional Axillary Dissection
- interventionNames
- Procedure: Conventional Axillary Dissection
Primary outcomes (1)
- measure
- Survival without recurrence
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Women older than 18 years with clinically node-negative operable unifocal N0 breast cancer (clinical tumour size \< 30 mm). * Written consent is obtained from all patients before randomization.
References
Publications (1)
- RESULTRoy P, Leizorovicz A, Villet R, Mercier C, Bobin JY. Systematic versus sentinel-lymph-node-driven axillary-lymph-node dissection in clinically node-negative patients with operable breast cancer. Results of the GF-GS01 randomized trial. Breast Cancer Res Treat. 2018 Jul;170(2):303-312. doi: 10.1007/s10549-018-4733-y. Epub 2018 Mar 10. PMID 29526019