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Axillary Reverse Mapping for Invasive Carcinoma of the Breast

This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: March 25, 2008
Last updated: August 1, 2012
Last verified: August 2012

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.

Condition Intervention Phase
Breast Cancer Procedure: Axillary Reverse Mapping Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Axillary Reverse Mapping for Invasive Carcinoma of the Breast

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Identification Rate for Feasibility of ARM in Patients Undergoing Axillary Lymph Node Dissection for breast cancer therapy [ Time Frame: 2 years for overall study ]
    Axillary reverse mapping (ARM) performed using 2 - 5cc of isosulfan blue, injected into the inner arm prior to skin incision for the axillary lymph node dissection. Blue channels identified during surgery and locations compared to axillary vein. Any blue nodes within the standard axillary lymph node dissection field removed then sent to pathology as a separate specimen labeled "axillary reverse mapping nodes" and evaluated with serial sectioning, and hematoxylin-eosin stain (H&E) as well as immunohistochemistry.

Secondary Outcome Measures:
  • Incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by ARM [ Time Frame: 2 years ]

Enrollment: 35
Study Start Date: March 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Axillary Reverse Mapping (ARM) Procedure: Axillary Reverse Mapping
Lymphazurin, isosulfan blue dye, injected into arm then a standard axillary lymph node surgery to remove any blue dyed lymph nodes found (lymph nodes that have traveled down the drainage pathways).

Detailed 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.


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00645541

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00645541     History of Changes
Other Study ID Numbers: 2007-0951
Study First Received: March 25, 2008
Last Updated: August 1, 2012

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Carcinoma of the Breast
Lymph Nodes
Axillary Reverse Mapping

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on September 21, 2017