Clinical trial NCT01146158: Axillary Reverse Mapping for Breast Carcinomas
Official title: Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axillary Dissection
Keywords: Axillary dissection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Success of the principal objectives is qualified as finding one or more radioactive node in zone D
timeFrame: 1 day
Secondary outcomes:
measure: Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node
timeFrame: 15 days
measure: Evaluate the correlation between clinical and histological results
timeFrame: 15 days
measure: Evaluate the morbidity associated with Axillary Dissection.
timeFrame: 1 year, 2 years and 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital European Georges Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claude NOS, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1245/s10434-007-9450-4. Epub 2007 Jun 5.
citation: 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.