Axillary Reverse Mapping for Breast Carcinomas (SENTIBRAS)

Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.

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.

Study Overview

• Status: Completed
• Conditions: Axillary Dissection
• Intervention / Treatment: Procedure: Axillary dissection for breast carcinomas

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hospital european Georges pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgery Axillary dissection	Procedure: Axillary dissection for breast carcinomas; surgery Axillary dissection; Other Names: surgery Axillary dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the principal objectives is qualified as finding one or more radioactive node in zone D	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	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Claude NOS, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Axillary dissection
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: P070154