Axillary Reverse Mapping for Breast Carcinomas

Phase 3

Completed

• Conditions: Axillary Dissection
• Interventions: Procedure: Axillary dissection for breast carcinomas

• Registration Number: NCT01146158
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 limb. This represents a new surgical technique that is the focus of recent surgical interest.

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 limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.

Study Timeline

• Status Verified: 2009-05
• Study Start: 2009-11
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
surgery Axillary dissection	Axillary dissection for breast carcinomas	surgery Axillary dissection

Primary Outcome Measures

Name	Time	Method
Success of the principal objectives is qualified as finding one or more radioactive node in zone D	1 day	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 Outcome Measures

Name	Time	Method
Evaluate the correlation between clinical and histological results	15 days	Evaluate the correlation between clinical and histological results
Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node	15 days	Evaluate the incidence of metastatic or micro-metastatic disease within
Evaluate the morbidity associated with Axillary Dissection.	1 year, 2 years and 5 years	Evaluate the morbidity associated with Axillary Dissection.

Trial Locations

Locations (1)

Hospital European Georges Pompidou; 🇫🇷 Paris, France