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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
Must not have
Female breast cancer patients who have a history of ALND
Female patients requiring bilateral ALND for the treatment of their breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman with breast cancer and have had lymph nodes removed.
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I need both sides of my lymph nodes removed due to breast cancer.
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I had a sentinel lymph node biopsy for breast cancer.
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I do not speak English.
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My breast cancer has returned in the underarm area.
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I am a male diagnosed with breast cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
the number of patients that had a decrease incidence of lymphedema

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,969 Previous Clinical Trials
597,255 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
~33 spots leftby Jan 2026
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