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

Trial Status: Active

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.

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 on the ipsilateral side 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 (by clinical exam).
  • 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
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  • Creatinine: =< 1.5 x upper limit of normal (ULN).

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-686-8274

California

La Jolla
UC San Diego Moores Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-822-5354
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: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 510-204-1414
Santa Monica
Saint John's Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-582-7448

Colorado

Edwards
Shaw Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-569-7429

Delaware

Frankford
Beebe South Coastal Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100
Newark
Christiana Care Health System-Christiana Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Fort Lauderdale
Holy Cross Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-267-7748
Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Phone: 352-273-8010
Jacksonville
Baptist MD Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 904-202-7468
Mayo Clinic in Florida
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Orlando Health Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 321-841-7246
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647

Georgia

Fayetteville
Piedmont Fayette Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923

Illinois

Chicago
Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-942-5498
Oak Lawn
Advocate Christ Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-323-8622

Indiana

Goshen
Goshen Center for Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 574-364-2973

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Overland Park
University of Kansas Hospital-Indian Creek Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-588-3671

Kentucky

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

Maryland

Annapolis
Anne Arundel Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-481-1320

Michigan

Bay City
McLaren Cancer Institute-Bay City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
Farmington Hills
Weisberg Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 313-576-9790
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Wyandotte
Henry Ford Wyandotte Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: nhay@hfhs.org

New Jersey

Camden
Cooper Hospital University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 856-325-6757
Sewell
Sidney Kimmel Cancer Center Washington Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-600-9151
Somerville
Robert Wood Johnson University Hospital Somerset
Status: ACTIVE
Contact: Site Public Contact
Phone: 908-685-2481

New York

East Hills
Cancer Institute at Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-305-6361
Rochester
Pluta Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
West Islip
Good Samaritan Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 631-376-4444

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Akron
Cleveland Clinic Akron General
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Beachwood
UHHS-Chagrin Highlands Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Chardon
Geauga Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-584-7698
Cleveland
Case Western Reserve University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Middleburg Heights
UH Seidman Cancer Center at Southwest General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Parma
University Hospitals Parma Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Ravenna
University Hospitals Portage Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-641-2422
Sandusky
UH Seidman Cancer Center at Firelands Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Wadsworth
University Hospitals Sharon Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
West Chester
University of Cincinnati Cancer Center-West Chester
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-584-7698
Westlake
UH Seidman Cancer Center at Saint John Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
UHHS-Westlake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Pennsylvania

Philadelphia
Penn Presbyterian Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923
Pennsylvania Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-789-7366
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-600-9151
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-474-9892
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073
Wilkes-Barre
Geisinger South Wilkes-Barre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Geisinger Wyoming Valley / Henry Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251

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: ACTIVE
Contact: Site Public Contact
Conroe
MD Anderson in The Woodlands
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-632-6789
Dallas
Parkland Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-590-5582
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
Galveston
University of Texas Medical Branch
Status: ACTIVE
Contact: Site Public Contact
Phone: 409-772-1950
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-798-1354
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
MD Anderson West Houston
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
League City
MD Anderson League City
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789
UTMB Cancer Center at Victory Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-917-8906
Sugar Land
MD Anderson in Sugar Land
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789

Virginia

Richmond
VCU Massey Cancer Center at Stony Point
Status: ACTIVE
Contact: Site Public Contact
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Washington

Issaquah
Swedish Cancer Institute-Issaquah
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Seattle
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086

Wisconsin

Brookfield
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
Grafton
Aurora Cancer Care-Grafton
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Milwaukee
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Wauwatosa
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-635-6420
West Allis
Aurora West Allis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304

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 Phase III

Trial Type Prevention

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
V. Suzanne Klimberg

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