Axillary Reverse Mapping for Breast Carcinomas

Axillary Dissection Clinical Trial

— SENTIBRAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146158
• Other study ID #: P070154
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2010
• Last updated: April 7, 2015
• Start date: November 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Axillary Dissection
• Breast Neoplasms

Intervention

Procedure:
• Axillary dissection for breast carcinomas
surgery Axillary dissection

Locations

Country	Name	City	State
France	Hospital European Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. Epub 2007 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Evaluate the correlation between clinical and histological results	Evaluate the correlation between clinical and histological results	15 days	Yes
Secondary	Evaluate the morbidity associated with Axillary Dissection.	Evaluate the morbidity associated with Axillary Dissection.	1 year, 2 years and 5 years	No