Axillary Reverse Mapping for Invasive Carcinoma of the Breast

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Axillary Reverse Mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT00645541

2007-0951

Details and patient eligibility

About

Primary Objectives:

• To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing axillary lymph node dissection for breast cancer therapy.
• To determine the incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by axillary reverse mapping.
• To determine the safety of axillary reverse mapping.

Full description

Lymphazurin is a blue dye used usually in breast cancer surgery to trace the drainage pathway that flows to lymph nodes. The dye will travel to the lymph system and will end up in the lymph nodes that are draining the arm.

In this study, lymphazurin will be used to find the drainage routes from your arm, rather than your breast.

AXILLARY REVERSE MAPPING:

Before axillary lymph node surgery, your surgeon will inject lymphazurin into your arm. Your surgeon will watch how the dye flows and find the channels and nodes draining the arm. You will then have standard axillary lymph node (lymph nodes found under the arm) surgery. Any lymph nodes found that are dyed blue (lymph nodes that have traveled down the drainage pathways) that would normally be removed will be removed and sent to the pathology department. Pathologists will check the nodes to see if they have breast cancer cells in them. Also as part of routine care, all other axillary lymph nodes draining the breast will be removed and checked for breast cancer cells.

This is an investigational study. Lymphazurin is FDA approved and commercially available. The use of lymphazurin with axillary reverse mapping is investigational.

Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with invasive carcinoma of the breast planning to undergo axillary lymph node dissection at M. D. Anderson Cancer Center.
• Eastern Cooperative Oncology Group (ECOG) performance status of equal to or less than 3.

Exclusion criteria

• Patients with known allergies to blue dye or other contraindications to Lymphazurin.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Axillary Reverse Mapping (ARM)

Experimental group

Treatment:

Procedure: Axillary Reverse Mapping