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

StatusActive, Not Recruiting
PhasePhase 3
Started2020-01-22
View on ClinicalTrials.gov ↗

Amendment history

2026-02-25
Study Status v13
Primary completion date2026-01→2027-01
Completion date2026-01→2027-01
2025-11-05
2 amendments v11-v12
2 re-verifications since 2024-11-05, no change to tracked fields
2023-12-20
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 7 of 7 sites
2023-08-21
Study Status, Study Design v9
Primary completion date2024-01→2026-01
Completion date2024-01→2026-01
Enrollment target174→180
2023-03-13
Study Status, Outcome Measures v8
Re-verified, no change to tracked fields
Show 7 earlier versions
2022-10-03
Study Status, Arms and Interventions v7
Primary completion date2023-01→2024-01
Completion date2023-01→2024-01
2022-06-27
Study Status, Contacts/Locations v6
Study sites7 entries, revised
MemoralMemorial Sloan Kettering Basking Ridge (Consent Onlyand Followup) MemoralMemorial Sloan Kettering Monmouth (Consent Only) MemoralMemorial Sloan Kettering Westchester (Consent Only)
2022-01-06
Study Status v5
Primary completion date2022-01→2023-01
Completion date2022-01→2023-01
2021-01-06
Study Status, Eligibility v4
Eligibility criteria+19 characters
[...] D, 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 [...] breast cancer Female breast patients treated with SLNBx only Known allergy to dye used in ILR
2020-09-02
Study Status, Arms and Interventions, Contacts/Locations v3
Study sites6→7
2020-04-16
Study Status, Contacts/Locations v2
Study sites5→6
2020-03-18
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v1
Study sites4→5
Eligibility criteria+89 characters
[...] ing surgery Exclusion Criteria: 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 Fem [...]
2020-01-24
Original filing
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
Trial Details
NCT Number NCT04241341
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Breast Cancer Lymphedema
Enrollment 180 participants
Start Date 2020-01-22
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-27