Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group I (ALND)
Patients receive isosulfan blue SC and undergo ALND.
  • Drug: Isosulfan Blue
    Given SC
  • Procedure: Axillary Lymph Node Dissection
    Undergo ALND
    Other names:
    • ALND
    • axillary dissection
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Group II (ARM, ALND)
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
  • Drug: Isosulfan Blue
    Given SC
  • Procedure: Axillary Lymph Node Dissection
    Undergo ALND
    Other names:
    • ALND
    • axillary dissection
  • Procedure: Mapping
    Undergo ARM
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Contra Costa Regional Medical Center
Martinez, California 94553-3156
Contact:
Site Public Contact
925-957-5400

Alta Bates Summit Medical Center - Summit Campus
Oakland, California 94609
Contact:
Site Public Contact
510-204-1414

Holy Cross Hospital
Fort Lauderdale, Florida 33308
Contact:
Site Public Contact
954-267-7750

University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
Contact:
Site Public Contact
352-273-8010
cancer-center@ufl.edu

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015

UF Cancer Center at Orlando Health
Orlando, Florida 32806
Contact:
Site Public Contact
321-841-7246
CancerClinicalTrials@orlandohealth.com

Piedmont Fayette Hospital
Fayetteville, Georgia 30214
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622

Goshen Center for Cancer Care
Goshen, Indiana 46526
Contact:
Site Public Contact
574-364-2973
cccois@goshenhealth.com

University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429

McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Wyandotte Hospital
Wyandotte, Michigan 48192
Contact:
Site Public Contact
nhay@hfhs.org

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
Contact:
Site Public Contact
212-305-6361
nr2616@cumc.columbia.edu

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Cleveland Clinic Akron General
Akron, Ohio 44307
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-558-4553
uchealthnews@uc.edu

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

University Pointe
West Chester, Ohio 45069
Contact:
Site Public Contact
clinicaltrials@ucphysicians.com

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Women and Infants Hospital
Providence, Rhode Island 02905
Contact:
Site Public Contact
401-274-1122

UTMB Health Angleton Danbury Campus
Angleton, Texas 77515
Contact:
Site Public Contact
vsklimbe@utmb.edu

Parkland Memorial Hospital
Dallas, Texas 75235
Contact:
Site Public Contact
214-590-5582
canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

University of Texas Medical Branch
Galveston, Texas 77555-0565
Contact:
Site Public Contact
409-772-1950
clinical.research@utmb.edu

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

UTMB Cancer Center at Victory Lakes
League City, Texas 77573
Contact:
Site Public Contact
800-917-8906

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

More Details

NCT ID
NCT03927027
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

V. Suzanne Klimberg, MD, PhD
501-680-0779
Vsklimbe@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.