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

Status: Active

Description

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.

Eligibility Criteria

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 ultrasound (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 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  • Creatinine: =< 1.5 x upper limit of normal (ULN).

Locations & Contacts

California

Martinez
Contra Costa Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 925-957-5400
Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: Active
Contact: Site Public Contact
Phone: 510-204-1414

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Site Public Contact
Phone: 352-273-8010
Email: cancer-center@ufl.edu
Jacksonville
Mayo Clinic in Florida
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com

Kentucky

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: Active
Contact: Site Public Contact
Phone: 502-562-3429

New Jersey

Somerville
Robert Wood Johnson University Hospital Somerset
Status: Active
Contact: Site Public Contact
Phone: 908-685-2481

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Pennsylvania

Wilkes-Barre
Geisinger South Wilkes-Barre
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu

Rhode Island

Providence
Women and Infants Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-274-1122

Texas

Angleton
UTMB Health Angleton Danbury Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: vsklimbe@utmb.edu
Galveston
University of Texas Medical Branch
Status: Active
Contact: Site Public Contact
Phone: 409-772-1950
Email: clinical.research@utmb.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org
League City
UTMB Cancer Center at Victory Lakes
Status: Active
Contact: Site Public Contact
Phone: 800-917-8906

Trial Objectives and Outline

PRIMARY OBJECTIVE:

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 OBJECTIVE:

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.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Prevention

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
V. Suzanne Klimberg

Trial IDs

Primary ID A221702
Secondary IDs NCI-2018-02445
Clinicaltrials.gov ID NCT03927027