Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
NCT03927027 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 534
Last updated 2026-04-21
Summary
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.
Conditions
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
Interventions
- DRUG
-
Isosulfan Blue
Given SC
- PROCEDURE
-
Axillary Lymph Node Dissection
Undergo ALND
- PROCEDURE
-
Mapping
Undergo ARM
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
V. Suzanne Klimberg, MD, PhD · University of Texas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-29
- Primary Completion
- 2025-11-26
- Completion
- 2027-01-31
Countries
- United States
Study Locations
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