Clinical trial · Interventional
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
NCT00293865CI-TRIAL-00021824GATAcompletedN/AClinicalTrials.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)
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.
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 |
|---|---|---|---|
| GAS | Procedure | — | UNRESOLVED |
| sentinel node | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- false negatives
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Previous conservative surgical biopsy * Secondary pathological diagnosis of infiltrative cancer * No clinically involved axillary node (N0) * No previous neoadjuvant treatment * Performance status European Cancer Conference (ECCO) Grade ≤ 1 * Patient's written informed consent to participate in the study according to French law * Surgeon must have performed its learning curve Exclusion Criteria: * Lack of infiltrative breast carcinoma (in situ) pT4d \> N0 * Breast cancer relapse * Pregnancy * Known patent blue allergy * Indication for radical or partial mastectomy * Patient unable to understand the trial
References
Publications (1)
- DERIVEDRenaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupre PF, Fritel X, Ngo C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20. PMID 27214241