Axillary Reverse Mapping for Breast Carcinomas (SENTIBRAS)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Axillary Dissection

Treatments: Procedure: Axillary dissection for breast carcinomas

Study type: Interventional

Funder types: Other

Identifiers

NCT01146158

P070154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

surgery Axillary dissection

Experimental group

Description:

surgery Axillary dissection

Treatment:

Procedure: Axillary dissection for breast carcinomas