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Axillary Reverse Mapping in Breast Cancer

Phase 2
19 Years
Not Enrolling
Breast Cancer

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Trial Information

Axillary Reverse Mapping in Breast Cancer

This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM)
procedure for patients presenting with breast cancer requiring lymph node evaluation. The
study will enroll 100 subjects, and will have two study arms: one for patients requiring
only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full
ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be
compared to its procedure-appropriate historical control for evidence of decrease in the
1-year lymphedema rate among patients undergoing SLNB or ALND.

Additional data will be collected on the treatment population's (a) variability in location
of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with
success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This
additional data will add to our level of knowledge and experience regarding lymph node

Inclusion Criteria:

1. 19-100 years old

2. Not pregnant or breastfeeding

3. Breast cancer requiring LN evaluation for the breast

4. Willing participation following an informed consent process

Exclusion Criteria:

1. Patient < 19 y/o or > 100 y/o

2. Pregnant or breastfeeding

3. Allergy to blue dye

4. Locally advanced axillary disease

5. History of receiving neoadjuvant chemotherapy treatment

6. Prior axillary surgery or radiation therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Map arm lymphatic drainage system in the axilla

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Sam Wiseman, MD, FRCSC, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia


Canada: Health Canada

Study ID:




Start Date:

June 2013

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • sentinel lymph node biopsy (SLNB)
  • axillary lymph node dissection (ALND)
  • lymphatics
  • blue dye
  • Breast Neoplasms