Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

In brief

This phase III trial studies 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.

Key facts

Study ID

NCT03927027

Run by

Alliance for Clinical Trials in Oncology

People needed

534

Starts

2019-07-29

Expected to finish

2027-01-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally meet one of the following conditions:
• 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 i) negative clinical exam and/or ii) negative axillary US and/or iii) 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.
• o 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).

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Saint John's Cancer Institute — Santa Monica, California, United States
• Shaw Cancer Center — Edwards, Colorado, United States
• Beebe South Coastal Health Campus — Frankford, Delaware, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
• Piedmont Fayette Hospital — Fayetteville, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Goshen Center for Cancer Care — Goshen, Indiana, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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