A Study to Examine Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

Overview

About this study

The purpose of this study is to examine how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by:
    • negative clinical exam; and/or
    • negative axillary US; and/or
    • negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
  • Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
  • Patients will be staged according to the TNM staging system. 
  • Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB.
    •  Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration. 
  • No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in situ [DCIS]). Lobular breast carcinoma in situ (LCIS) and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration). 
  • No bilateral invasive breast cancer. 
  • No matted nodes.
  • No history of lymphedema of either arm.
  • No known allergies blue dyes, including make-up containing blue dye.
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English. 
  • Female : Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer. 
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 
  • Creatinine: ≤ 1.5 x upper limit of normal (ULN).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Sarah McLaughlin, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions