Axillary Reverse Mapping for Invasive Carcinoma of the Breast

Breast Cancer Clinical Trial

Official title: Axillary Reverse Mapping for Invasive Carcinoma of the Breast

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00645541
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: March 2008
• Completion date: November 2010