NCT03927027

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

ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVES: 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.

Conditions

• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-29
• Primary completion: 2026-11-26
• Completion: 2027-01-01
• First posted: 2019-04-25
• Last updated: 2026-01-26

Locations

96 sites across 1 country: United States