Axillary Reverse Mapping for Breast Carcinomas

NCT ID: NCT01146158

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Axillary Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgery Axillary dissection

surgery Axillary dissection

Group Type: EXPERIMENTAL

Axillary dissection for breast carcinomas

Intervention Type: PROCEDURE

surgery Axillary dissection

Interventions

Axillary dissection for breast carcinomas

surgery Axillary dissection

Intervention Type: PROCEDURE

Other Intervention Names

surgery Axillary dissection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claude NOS, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hospital European Georges Pompidou

Paris, , France

Countries

France

References

Nos 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.

Reference Type: BACKGROUND

PMID: 17549570 (View on PubMed)

Nos 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.

Reference Type: BACKGROUND

PMID: 18618185 (View on PubMed)

Other Identifiers

P070154

Identifier Type: -

Identifier Source: org_study_id