Clinical trial · Interventional
Axillary Reverse Mapping for Breast Carcinomas
Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.
NCT01146158CI-TRIAL-00017429SENTIBRAScompletedPhase 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)
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.
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 |
|---|---|---|---|
| Axillary Dissection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary dissection for breast carcinomas | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- surgery Axillary dissection
- description
- surgery Axillary dissection
- interventionNames
- Procedure: Axillary dissection for breast carcinomas
Primary outcomes (1)
- measure
- Success of the principal objectives is qualified as finding one or more radioactive node in zone D
- timeFrame
- 1 day
- description
- Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein. If all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective
Secondary outcomes (3)
- measure
- Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Indication for formal Axillary Dissection (AD) * N0 patient with a large tumor: T3 * N1 patient * N2 patient with axillary imaging showing limited node involvement(1-4N+). * Secondary AD after a positive sentinel node ( pN1, pN1(mi)) * AD after préopérative chemotherapy in a patient initially N+. * Age between 18 and 70 * Signature of the consent form. * Patients beneficiary of the Social Security Exclusion Criteria: * N0 patient with an indication of Sentinel Node biopsy * N2 patient with axillary imaging showing suspected node involvement \>4N+. * N3 patient * Age over 70 * Pregnancy * Blue dye allergy * Mentally deficient patient
References
Publications (2)
- BACKGROUNDNos C, Lesieur B, Clough KB, Lecuru F. Blue dye injection in the arm in order to conserve the lymphatic drainage of the arm in breast cancer patients requiring an axillary dissection. Ann Surg Oncol. 2007 Sep;14(9):2490-6. doi: 10.1245/s10434-007-9450-4. Epub 2007 Jun 5. PMID 17549570
- BACKGROUNDNos C, Kaufmann G, Clough KB, Collignon MA, Zerbib E, Cusumano P, Lecuru F. Combined axillary reverse mapping (ARM) technique for breast cancer patients requiring axillary dissection. Ann Surg Oncol. 2008 Sep;15(9):2550-5. doi: 10.1245/s10434-008-0030-z. Epub 2008 Jul 11. PMID 18618185