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New mapping technique may stop arm swelling in breast cancer patients

NCT ID NCT03927027

Disease control Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a technique called axillary reverse mapping (ARM) to see if it can prevent lymphedema—painful arm swelling—after breast cancer surgery. About 534 people with stage I-III breast cancer will be followed for 3 years. The goal is to find out if mapping and preserving lymph vessels during lymph node removal reduces swelling without increasing cancer recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

534 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer stage I Breast cancer stage II Breast cancer stage III

Contacts and locations

Locations

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699, United States

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609, United States

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401, United States

  • Ascension Medical Group Southeast Wisconsin - Mayfair Road

    Wauwatosa, Wisconsin, 53226, United States

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045, United States

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090, United States

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311, United States

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233, United States

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227, United States

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030, United States

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971, United States

  • Beebe South Coastal Health Campus

    Frankford, Delaware, 19945, United States

  • Cancer Institute at Saint Francis Hospital

    East Hills, New York, 11548, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718, United States

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156, United States

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103, United States

  • Geauga Hospital

    Chardon, Ohio, 44024, United States

  • Geisinger South Wilkes-Barre

    Wilkes-Barre, Pennsylvania, 18765, United States

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711, United States

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795, United States

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526, United States

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038, United States

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322, United States

  • Henry Ford Wyandotte Hospital

    Wyandotte, Michigan, 48192, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson League City

    League City, Texas, 77573, United States

  • MD Anderson West Houston

    Houston, Texas, 77079, United States

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478, United States

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706, United States

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213, United States

  • Mount Carmel New Albany Surgical Hospital

    New Albany, Ohio, 43054, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Parkland Memorial Hospital

    Dallas, Texas, 75235, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214, United States

  • Pluta Cancer Center

    Rochester, New York, 14623, United States

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint John's Cancer Institute

    Santa Monica, California, 90404, United States

  • Shaw Cancer Center

    Edwards, Colorado, 81632, United States

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey, 08080, United States

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029, United States

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122, United States

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UH Seidman Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870, United States

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060, United States

  • UH Seidman Cancer Center at Saint John Medical Center

    Westlake, Ohio, 44145, United States

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130, United States

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122, United States

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573, United States

  • UTMB Health Angleton Danbury Campus

    Angleton, Texas, 77515, United States

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129, United States

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266, United States

  • University Hospitals Sharon Health Center

    Wadsworth, Ohio, 44281, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069, United States

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160, United States

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565, United States

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235, United States

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334, United States

  • Women and Infants Hospital

    Providence, Rhode Island, 02905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.