Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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 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 is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

516

Study ID:

NCT03927027

Recruitment Status:

Recruiting

Sponsor:

Alliance for Clinical Trials in Oncology

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 87 Locations for this study

See Locations Near You

University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States More Info
Site Public Contact
Contact
501-686-8274
Daniela Ochoa
Principal Investigator
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States More Info
Site Public Contact
Contact
858-822-5354
[email protected]
Sarah L. Blair
Principal Investigator
Contra Costa Regional Medical Center
Martinez California, 94553, United States More Info
Site Public Contact
Contact
925-957-5400
Lisa Bailey
Principal Investigator
Alta Bates Summit Medical Center - Summit Campus
Oakland California, 94609, United States
Saint John's Cancer Institute
Santa Monica California, 90404, United States More Info
Site Public Contact
Contact
310-582-7448
Janie G. Weng Grumley
Principal Investigator
Beebe South Coastal Health Campus
Frankford Delaware, 19945, United States More Info
Site Public Contact
Contact
302-645-3100
[email protected]
Gregory A. Masters
Principal Investigator
Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
Site Public Contact
Contact
302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States More Info
Site Public Contact
Contact
302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States More Info
Site Public Contact
Contact
302-645-3100
[email protected]
Gregory A. Masters
Principal Investigator
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables Florida, 33146, United States More Info
Site Public Contact
Contact
305-243-2647
Eli Avisar
Principal Investigator
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach Florida, 33442, United States More Info
Site Public Contact
Contact
305-243-2647
Eli Avisar
Principal Investigator
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States More Info
Site Public Contact
Contact
954-267-7748
Leonard J. Seigel
Principal Investigator
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States More Info
Site Public Contact
Contact
352-273-8010
[email protected]
Lisa R. Spiguel
Principal Investigator
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Site Public Contact
Contact
904-202-7468
Laila Samiian
Principal Investigator
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States More Info
Site Public Contact
Contact
855-776-0015
Sarah McLaughlin
Principal Investigator
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States More Info
Site Public Contact
Contact
305-243-2647
Eli Avisar
Principal Investigator
UM Sylvester Comprehensive Cancer Center at Kendall
Miami Florida, 33176, United States More Info
Site Public Contact
Contact
305-243-2647
Eli Avisar
Principal Investigator
Orlando Health Cancer Institute
Orlando Florida, 32806, United States More Info
Site Public Contact
Contact
321-841-7246
[email protected]
Danielle Henry
Principal Investigator
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation Florida, 33324, United States More Info
Site Public Contact
Contact
305-243-2647
Eli Avisar
Principal Investigator
Piedmont Fayette Hospital
Fayetteville Georgia, 30214, United States More Info
Site Public Contact
Contact
888-823-5923
[email protected]
Geetha S. Rao
Principal Investigator
Rush University Medical Center
Chicago Illinois, 60612, United States More Info
Site Public Contact
Contact
312-942-5498
[email protected]
Cristina ODonoghue
Principal Investigator
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States More Info
Site Public Contact
Contact
800-323-8622
Ameer Gomberawalla
Principal Investigator
Goshen Center for Cancer Care
Goshen Indiana, 46526, United States More Info
Site Public Contact
Contact
574-364-2973
[email protected]
Fiona N. Denham
Principal Investigator
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Jamie L. Wagner
Principal Investigator
University of Kansas Hospital-Indian Creek Campus
Overland Park Kansas, 66211, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Jamie L. Wagner
Principal Investigator
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Jamie L. Wagner
Principal Investigator
The James Graham Brown Cancer Center at University of Louisville
Louisville Kentucky, 40202, United States
Anne Arundel Medical Center
Annapolis Maryland, 21401, United States More Info
Site Public Contact
Contact
443-481-1320
[email protected]
Rubie S. Jackson
Principal Investigator
McLaren Cancer Institute-Bay City
Bay City Michigan, 48706, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township Michigan, 48038, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Jessica M. Bensenhaver
Principal Investigator
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Jessica M. Bensenhaver
Principal Investigator
Weisberg Cancer Treatment Center
Farmington Hills Michigan, 48334, United States
Henry Ford West Bloomfield Hospital
West Bloomfield Michigan, 48322, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Jessica M. Bensenhaver
Principal Investigator
Henry Ford Wyandotte Hospital
Wyandotte Michigan, 48192, United States More Info
Site Public Contact
Contact
[email protected]
Jessica M. Bensenhaver
Principal Investigator
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States More Info
Site Public Contact
Contact
856-325-6757
Kahyun Yoon-Flannery
Principal Investigator
Robert Wood Johnson University Hospital Somerset
Somerville New Jersey, 08876, United States More Info
Site Public Contact
Contact
908-685-2481
[email protected]
Deborah A. Lue
Principal Investigator
Cancer Institute at Saint Francis Hospital
East Hills New York, 11548, United States More Info
Site Public Contact
Contact
773-702-9171
[email protected]
Ellis G. Levine
Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States More Info
Site Public Contact
Contact
212-305-6361
[email protected]
Bret Taback
Principal Investigator
Pluta Cancer Center
Rochester New York, 14623, United States More Info
Site Public Contact
Contact
888-823-5923
[email protected]
Paul M. Barr
Principal Investigator
University of Rochester
Rochester New York, 14642, United States More Info
Site Public Contact
Contact
585-275-5830
Paul M. Barr
Principal Investigator
Good Samaritan Hospital Medical Center
West Islip New York, 11795, United States More Info
Site Public Contact
Contact
631-376-4444
Ellis G. Levine
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States More Info
Site Public Contact
Contact
877-668-0683
[email protected]
Kristalyn K. Gallagher
Principal Investigator
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States More Info
Site Public Contact
Contact
336-713-6771
Akiko Chiba
Principal Investigator
Cleveland Clinic Akron General
Akron Ohio, 44307, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Andrew H. Fenton
Principal Investigator
UHHS-Chagrin Highlands Medical Center
Beachwood Ohio, 44122, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
Geauga Hospital
Chardon Ohio, 44024, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati Ohio, 45219, United States More Info
Site Public Contact
Contact
513-584-7698
[email protected]
Elizabeth A. Shaughnessy
Principal Investigator
Case Western Reserve University
Cleveland Ohio, 44106, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Stephanie A. Valente
Principal Investigator
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Site Public Contact
Contact
800-293-5066
[email protected]
Ko Un Park
Principal Investigator
Mount Carmel East Hospital
Columbus Ohio, 43213, United States More Info
Site Public Contact
Contact
614-488-2118
[email protected]
Timothy D. Moore
Principal Investigator
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor Ohio, 44060, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights Ohio, 44130, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
University Hospitals Parma Medical Center
Parma Ohio, 44129, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
University Hospitals Portage Medical Center
Ravenna Ohio, 44266, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky Ohio, 44870, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
University Hospitals Sharon Health Center
Wadsworth Ohio, 44281, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
University of Cincinnati Cancer Center-West Chester
West Chester Ohio, 45069, United States More Info
Site Public Contact
Contact
513-584-7698
[email protected]
Elizabeth A. Shaughnessy
Principal Investigator
UH Seidman Cancer Center at Saint John Medical Center
Westlake Ohio, 44145, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
UHHS-Westlake Medical Center
Westlake Ohio, 44145, United States More Info
Site Public Contact
Contact
800-641-2422
[email protected]
Megan E. Miller
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
William C. Dooley
Principal Investigator
Penn Presbyterian Medical Center
Philadelphia Pennsylvania, 19104, United States More Info
Site Public Contact
Contact
888-823-5923
[email protected]
Alina Mateo
Principal Investigator
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States More Info
Site Public Contact
Contact
800-474-9892
Alina Mateo
Principal Investigator
Pennsylvania Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Site Public Contact
Contact
800-789-7366
Alina Mateo
Principal Investigator
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh Pennsylvania, 15232, United States More Info
Site Public Contact
Contact
412-647-8073
Joanna Lee
Principal Investigator
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States
Geisinger South Wilkes-Barre
Wilkes-Barre Pennsylvania, 18765, United States
Women and Infants Hospital
Providence Rhode Island, 02905, United States More Info
Site Public Contact
Contact
401-274-1122
David A. Edmonson
Principal Investigator
UTMB Health Angleton Danbury Campus
Angleton Texas, 77515, United States More Info
Site Public Contact
Contact
[email protected]
V. S. Klimberg
Principal Investigator
MD Anderson in The Woodlands
Conroe Texas, 77384, United States More Info
Site Public Contact
Contact
866-632-6789
[email protected]
Sarah M. DeSnyder
Principal Investigator
Parkland Memorial Hospital
Dallas Texas, 75235, United States More Info
Site Public Contact
Contact
214-590-5582
[email protected]
Ann M. Leitch
Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Ann M. Leitch
Principal Investigator
University of Texas Medical Branch
Galveston Texas, 77555, United States More Info
Site Public Contact
Contact
409-772-1950
[email protected]
V. S. Klimberg
Principal Investigator
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
713-798-1354
[email protected]
Elizabeth T. Bonefas
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Sarah M. DeSnyder
Principal Investigator
MD Anderson West Houston
Houston Texas, 77079, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Sarah M. DeSnyder
Principal Investigator
MD Anderson League City
League City Texas, 77573, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Sarah M. DeSnyder
Principal Investigator
UTMB Cancer Center at Victory Lakes
League City Texas, 77573, United States More Info
Site Public Contact
Contact
800-917-8906
V. S. Klimberg
Principal Investigator
MD Anderson in Sugar Land
Sugar Land Texas, 77478, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Sarah M. DeSnyder
Principal Investigator
VCU Massey Cancer Center at Stony Point
Richmond Virginia, 23235, United States More Info
Site Public Contact
Contact
[email protected]
Kandace P. McGuire
Principal Investigator
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Site Public Contact
Contact
[email protected]
Kandace P. McGuire
Principal Investigator
Swedish Cancer Institute-Issaquah
Issaquah Washington, 98029, United States More Info
Site Public Contact
Contact
206-215-3086
[email protected]
Alison K. Conlin
Principal Investigator
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States More Info
Site Public Contact
Contact
206-215-3086
[email protected]
Alison K. Conlin
Principal Investigator
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield Wisconsin, 53045, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Hanadi BuAli
Principal Investigator
Aurora Cancer Care-Grafton
Grafton Wisconsin, 53024, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Joseph J. Weber
Principal Investigator
Aurora BayCare Medical Center
Green Bay Wisconsin, 54311, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Joseph J. Weber
Principal Investigator
Aurora Saint Luke's Medical Center
Milwaukee Wisconsin, 53215, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Joseph J. Weber
Principal Investigator
Aurora Sinai Medical Center
Milwaukee Wisconsin, 53233, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Joseph J. Weber
Principal Investigator
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-635-6420
[email protected]
Hanadi BuAli
Principal Investigator
Aurora West Allis Medical Center
West Allis Wisconsin, 53227, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Joseph J. Weber
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

516

Study ID:

NCT03927027

Recruitment Status:

Recruiting

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider