Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer Lymphedema

In brief

The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include: Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema

Key facts

Study ID

NCT04241341

Run by

Memorial Sloan Kettering Cancer Center

People needed

180

Starts

2020-01-22

Expected to finish

2027-01-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female breast cancer patients 18-75 years of age
• Patients consenting for unilateral ALND (prior history of SLNBx allowed if <6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
• 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

You may not qualify if…

• Male breast cancer patients
• Non-English speaking participants
• Female breast cancer patients with axillary recurrence
• Female breast cancer patients who have a history of ALND
• Female patients requiring bilateral ALND for the treatment of their breast cancer
• Female breast patients treated with SLNBx only

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent and Followup) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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