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
surgery.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Map arm lymphatic drainage system in the axilla
4 years
No
Sam Wiseman, MD, FRCSC, FACS
Principal Investigator
University of British Columbia
Canada: Health Canada
H09-00926
NCT01038908
June 2013
June 2014
Name | Location |
---|