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Procedure

Immediate Lymphatic Reconstruction for Breast Cancer Lymphedema

Phase 3
Waitlist Available
Led By Michelle Coriddi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female breast cancer patients 18-75 years of age
Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is looking at whether having surgery to improve lymph flow after breast cancer surgery can reduce the risk of developing lymphedema, a common side effect.

Who is the study for?
This trial is for female breast cancer patients aged 18-75 who are undergoing unilateral axillary lymph node dissection (ALND) and have at least one cut lymphatic channel and vein for bypass. It's not open to men, women with axillary recurrence or previous ALND, those needing bilateral ALND, SLNBx only cases, or non-English speakers.Check my eligibility
What is being tested?
The study compares two surgical methods: ALND alone versus ALND with immediate lymphatic reconstruction. The goal is to see if the latter can reduce the risk of developing lymphedema. Quality of life and the impact of adding radiation therapy to both methods are also being evaluated.See study design
What are the potential side effects?
Potential side effects include risks associated with surgery such as infection, swelling (lymphedema), pain, numbness, and limited arm movement. Radiation therapy may add skin changes, fatigue, and other localized reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18-75 with breast cancer.
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My surgery will involve connecting a lymph channel and a vein.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
the number of patients that had a decrease incidence of lymphedema

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: axillary lymph node dissection with ILRExperimental Treatment3 Interventions
Group II: axillary lymph node dissection (ALND) without ILRActive Control3 Interventions

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,442 Total Patients Enrolled
Michelle Coriddi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
285 Total Patients Enrolled

Media Library

Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04241341 — Phase 3
Breast Cancer Lymphedema Research Study Groups: axillary lymph node dissection with ILR, axillary lymph node dissection (ALND) without ILR
Breast Cancer Lymphedema Clinical Trial 2023: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction Highlights & Side Effects. Trial Name: NCT04241341 — Phase 3
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04241341 — Phase 3

Frequently Asked Questions

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

Are there specific requirements for participants in this clinical trial?

"This clinical trial is specifically for breast cancer patients with lymphedema who are aged 18-75. Out of the 174 total possible participants, recruitment is still underway."

Answered by AI

Is the FDA's stance on Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction positive?

"Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction rates a 3 on Power's safety scale."

Answered by AI

Are there any available openings for this clinical trial?

"Yes, this trial is still open and recruiting patients, according to the most recent update on clinicaltrials.gov from October 3rd, 2020. The trial was first posted on January 22nd, 2020."

Answered by AI

For this test, are they only allowing people who are under 55 years old to participate?

"The age parameters for patients that wish to enroll in this trial are between 18 to 75 years old."

Answered by AI

Where is this trial being conducted?

"To make things more convenient for enrollees, this clinical trial is running at 10 sites. Some of these locations include Basking Ridge, Middletown, Harrison, and 10 other locations."

Answered by AI

The total enrollment for this research project is _____ participants.

"That is correct. The clinical trial is actively recruiting participants, with the first posting on 1/22/2020 and the most recent update on 10/3/2022. The study is looking for 174 participants at 10 sites."

Answered by AI

Who else is applying?

What state do they live in?
Delaware
How old are they?
65+
What site did they apply to?
Memoral Sloan Kettering Basking Ridge (Consent Only)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
2020. "Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04241341.
All > Lymphedema New York > Lymphedema
~51 spots leftby Jan 2026
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