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Axillary Reverse Mapping for Preventing Lymphedema in Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial looks at how well a surgery to preserve the lymph node drainage system around the breast works in preventing lymphedema after breast cancer surgery.

Who is the study for?
This trial is for women with breast cancer who are clinically node negative, meaning no signs of cancer in lymph nodes by exam or imaging, and haven't had prior axillary surgery except needle biopsy. They must have completed any neoadjuvant chemotherapy at least 2 weeks before joining the study and should not have a history of lymphedema or ipsilateral breast cancer.Check my eligibility
What is being tested?
The trial is testing axillary reverse mapping (ARM) to prevent lymphedema in patients undergoing axillary lymph node dissection as part of their treatment for breast cancer. ARM aims to preserve the natural drainage around the breast to reduce swelling after surgery.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Isosulfan Blue dye used in mapping procedures. Since this study focuses on preventing complications rather than introducing new drugs, fewer side effects are expected compared to drug trials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of upper extremity (UE) lymphedema
Secondary outcome measures
Change in health-related quality of life: LSIDS-A questionnaire scores
Incidence of regional recurrence
Filarial Elephantiases

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (ARM, ALND)Experimental Treatment5 Interventions
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
Group II: Group I (ALND)Active Control4 Interventions
Patients receive isosulfan blue SC and undergo ALND.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isosulfan Blue
2005
N/A
~80
Axillary Lymph Node Dissection
2004
Completed Phase 4
~530

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,122 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,151 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
V. Suzanne Klimberg, MD, PhDStudy ChairUniversity of Texas

Media Library

Axillary Lymph Node Dissection Clinical Trial Eligibility Overview. Trial Name: NCT03927027 — Phase 3
Breast Cancer Research Study Groups: Group I (ALND), Group II (ARM, ALND)
Breast Cancer Clinical Trial 2023: Axillary Lymph Node Dissection Highlights & Side Effects. Trial Name: NCT03927027 — Phase 3
Axillary Lymph Node Dissection 2023 Treatment Timeline for Medical Study. Trial Name: NCT03927027 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which areas is this research being conducted?

"Currently, there are 86 sites actively recruiting for this study. Some of these locations include the University of Pennsylvania/Abramson Cancer Center in Philadelphia, UM Sylvester Comprehensive Cancer Center at Plantation in Plantation, and UH Seidman Cancer Center at Saint John Medical Center in Westlake."

Answered by AI

What is the standard purpose of Axillary Lymph Node Dissection?

"chylous ascites often requires treatment through Axillary Lymph Node Dissection. This procedure can also help patients struggling with limb structure, lymphangiograph, and chylothorax."

Answered by AI

Are there any other ongoing research projects similar to this one involving Axillary Lymph Node Dissection?

"University of Oklahoma Health Sciences Center first published data on Axillary Lymph Node Dissection in 2019. Since that time, there have been 237 completed clinical trials and 1 active study. The latter is recruiting patients in Philadelphia, Pennsylvania."

Answered by AI

How many people have expressed interest in this experiment?

"This study is no longer recruiting patients. The date the study was first posted was May 31st, 2019, and the date of the most recent edit was March 22nd, 2022. There are other trials that may be of interest; there are 2400 studies recruiting patients with lymphedema and 1 Axillary Lymph Node Dissection trial that is currently enrolling participants."

Answered by AI

Has the FDA cleared Axillary Lymph Node Dissection for medical use?

"There is some data to support the efficacy of Axillary Lymph Node Dissection, and multiple rounds of data have been collected to support its safety. As such, our team has given it a score of 3."

Answered by AI

Are there any volunteer opportunities available for this research?

"Currently, this clinical trial is not recruiting patients. The study was posted on May 31st, 2019 and was last updated on March 22nd, 2022. If you are interested in other clinical trials, there are currently 2400 trials actively admitting participants with lymphedema and 1 trial for Axillary Lymph Node Dissection actively admitting patients."

Answered by AI

Who else is applying?

What state do they live in?
New York
Illinois
Delaware
How old are they?
65+
18 - 65
What site did they apply to?
Christiana Care Health System-Christiana Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
~88 spots leftby Apr 2025