Status:
COMPLETED
Axillary Reverse Mapping for Breast Carcinomas
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Axillary Dissection
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
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 l...
Detailed Description
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01146158
Start Date
November 1 2009
End Date
December 1 2012
Last Update
April 8 2015
Active Locations (1)
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1
Hospital European Georges Pompidou
Paris, France, 75015