AzTrials
AzTrials

Breast Cancer Stage IPhase 3NCT03927027

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

A Phase 3 study testing Isosulfan Blue, Axillary Lymph Node Dissection and Mapping in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Alliance for Clinical Trials in Oncology at 96 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Isosulfan Blue, Axillary Lymph Node Dissection and Mapping
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
534 participants
Where
96 sitesUnited States
Study dates
29 Jul 2019to Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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).

Who cannot join

None listed.

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

United States96 sites

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • UTMB Health Angleton Danbury Campus

    Angleton, Texas, 77515

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Institute at Saint Francis Hospital

    East Hills, New York, 11548

  • Shaw Cancer Center

    Edwards, Colorado, 81632

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Beebe South Coastal Health Campus

    Frankford, Delaware, 19945

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

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

    Houston, Texas, 77030

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • MD Anderson League City

    League City, Texas, 77573

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

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

    Miami, Florida, 33136

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

  • UH Seidman Cancer Center at Southwest General Hospital

    Middleburg Heights, Ohio, 44130

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Mount Carmel New Albany Surgical Hospital

    New Albany, Ohio, 43054

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

    New York, New York, 10032

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Pluta Cancer Center

    Rochester, New York, 14623

  • University of Rochester

    Rochester, New York, 14642

  • UH Seidman Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Saint John's Cancer Institute

    Santa Monica, California, 90404

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey, 08080

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

  • University Hospitals Sharon Health Center

    Wadsworth, Ohio, 44281

  • Ascension Medical Group Southeast Wisconsin - Mayfair Road

    Wauwatosa, Wisconsin, 53226

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795

  • UH Seidman Cancer Center at Saint John Medical Center

    Westlake, Ohio, 44145

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Geisinger South Wilkes-Barre

    Wilkes-Barre, Pennsylvania, 18765

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Henry Ford Wyandotte Hospital

    Wyandotte, Michigan, 48192

Other trials in United States

About this study

Official title: ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Isosulfan Blue, Axillary Lymph Node Dissection, Mapping, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isosulfan BlueDrug

    Given SC

  • Axillary Lymph Node DissectionProcedure or surgery

    Also called ALND, axillary dissection

    Undergo ALND

  • MappingProcedure or surgery

    Undergo ARM

  • Quality-of-Life AssessmentOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03927027
Study groupRoleWhat they receive
Group I (ALND)Active comparatorPatients receive isosulfan blue SC and undergo ALND.
Receives: Drug: Isosulfan Blue; Procedure: Axillary Lymph Node Dissection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (ARM, ALND)ExperimentalPatients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
Receives: Drug: Isosulfan Blue; Procedure: Axillary Lymph Node Dissection; Procedure: Mapping; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of upper extremity (UE) lymphedema

    Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire contains two different scales for intensity and distress measured from 1 (slight) to 5 (severe). The LSIDS-A questionnaire scores for swelling in the arm, decreased physical activity, pain in the arm, and loss of confidence in one's body will be evaluated for the change of baseline to 36 months using a two-sample, two-sided t-test.

    Measured: Up to 36 months post surgery

Secondary outcomes (3)

  1. Change in health-related quality of life: LSIDS-A questionnaire scores

    Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire scores at each time point, as well as the change from baseline will be compared between groups by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), will use a non-parametric procedure such as Wilcoxon rank sum test. Further analysis will include linear mixed model using data from all time points to compare the LSIDS-A questionnaire scores between the two treatment groups over time adjusting for other baseline characteristics. Will evaluate the pattern of missing data. If the drop-out rate is higher than expected, methods proposed by Hogan and Laird will be used to assess whether the presence of drop-outs affects inferences obtained from the repeated measures analyses. Appropriate methods will be used to address missingness.

    Measured: Baseline to 36 months

  2. Incidence of regional recurrence

    The technical success will be summarized using a binomial point estimate and 95% confidence interval (CI) and will be compared using a two-sample test of proportions.

    Measured: Up to 3 years

  3. Technical success of performance of axillary reverse mapping (ARM) procedure (defined as identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics)

    The cumulative incidence of regional recurrence will be summarized using the cumulative incidence function treating death without regional recurrence as the competing risk. Similar analysis methods described for the primary endpoint will be used to compare the cumulative incidence of regional recurrence between group I and II.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2019
  2. Study start29 Jul 2019
  3. Primary completion26 Nov 2025
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03927027
Sponsor's protocol ID
A221702
Other IDs
NCI-2018-02445, UG1CA189823
Status last verified
Apr 2026
First submitted
23 Apr 2019
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Levy AS, Murphy AI, Ishtihar S, Peysakhovich A, Taback B, Grant RT, Ascherman JA, Feldman S, Rohde CH. Lymphatic Microsurgical Preventive Healing Approach for the Primary Prevention of Lymphedema: A 4-Year Follow-Up. Plast Reconstr Surg. 2023 Feb 1;151(2):413-420. doi: 10.1097/PRS.0000000000009857. Epub 2022 Nov 15.

    PubMed 36696330

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Isosulfan Blue, Axillary Lymph Node Dissection and Mapping in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Alliance for Clinical Trials in Oncology at 96 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of upper extremity (UE) lymphedema (time frame: Up to 36 months post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03927027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in