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

  • End date
    Jan 11, 2024
  • participants needed
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 11 April 2022
breast surgery
carcinoma in situ
breast carcinoma
invasive breast cancer
ductal carcinoma in situ
lobular carcinoma in situ
sentinel lymph node biopsy
isosulfan blue


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.



I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping [ARM]) versus Group II (ARM).


I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A).

II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.

III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.


I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).

GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.

After completion of study, patients are followed up for 3 years.

Condition Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Treatment questionnaire administration, quality-of-life assessment, Axillary Lymph Node Dissection, Isosulfan Blue, Mapping
Clinical Study IdentifierNCT03927027
SponsorAlliance for Clinical Trials in Oncology
Last Modified on11 April 2022


Yes No Not Sure

Inclusion Criteria

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
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
No bilateral invasive breast cancer
situ [DCIS]). Lobular breast carcinoma in situ (LCIS) and benign disease are
No matted nodes
allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks
No history of lymphedema of either arm
before registration)
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
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Men are excluded from this study because the number of men with breast cancer is
Creatinine: =< 1.5 x upper limit of normal (ULN)
insufficient to provide a statistical basis for assessment of effects in this subpopulation
of people with breast cancer
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