Breast Cancer LymphedemaPhase 3NCT04241341
Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
A Phase 3 study testing Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction, Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction and quality-of-life questionnaires in people with Breast Cancer Lymphedema, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction, Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction and quality-of-life questionnaires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Jan 2020to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and Followup)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
Official title: A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection
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
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction, Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction, quality-of-life questionnaires, measured by arm volume
- Keywords
- Axillary Lymph Node Dissection, Lymphatic Reconstruction, 20-021
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary Lymph Node Dissection with Immediate Lymphatic ReconstructionProcedure or surgery
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection without Immediate Lymphatic ReconstructionProcedure or surgery
Current standard treatment at Memorial Sloan Kettering [MSK]).
quality-of-life questionnairesOther
Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them.
measured by arm volumeOther
Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. If a patient cannot return to Manhattan for these assessments but is seen by a lymphedema therapist in a regional location or at an institution outside of MSK as part of their routine cancer treatment, this data can be used in the final analysis
| Study group | Role | What they receive |
|---|---|---|
| axillary lymph node dissection with ILR | Experimental | Not described Receives: Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction; Other: quality-of-life questionnaires; Other: measured by arm volume |
| axillary lymph node dissection (ALND) without ILR | Active comparator | Not described Receives: Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction; Other: quality-of-life questionnaires; Other: measured by arm volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients that had a decrease incidence of lymphedema
as measured by arm volume will be a ≥10% increase in arm volume
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start22 Jan 2020
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to one of two groups: ALND with ILR (intervention group) and ALND without ILR (control group; current standard treatment at Memorial Sloan Kettering \[MSK\]).
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Coriddi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241341
- Sponsor's protocol ID
- 20-021
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT04241341
- Acronym / sponsor ID
- 20-021
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Axillary Lymph Node Dissection, Lymphatic Reconstruction, 20-021
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of two groups: ALND with ILR (intervention group) and ALND without ILR (control group; current standard treatment at Memorial Sloan Kettering [MSK]).
| Arm | Type | Receives |
|---|---|---|
| axillary lymph node dissection with ILR | Experimental | Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction, Other: quality-of-life questionnaires, Other: measured by arm volume |
| axillary lymph node dissection (ALND) without ILR | Active comparator | Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction, Other: quality-of-life questionnaires, Other: measured by arm volume |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary Lymph Node Dissection with Immediate Lymphatic ReconstructionAxillary Lymph Node Dissection with Immediate Lymphatic Reconstruction | Procedure or surgery | axillary lymph node dissection with ILR |
| Axillary Lymph Node Dissection without Immediate Lymphatic ReconstructionCurrent standard treatment at Memorial Sloan Kettering [MSK]). | Procedure or surgery | axillary lymph node dissection (ALND) without ILR |
| quality-of-life questionnairesFour validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. | Other | axillary lymph node dissection (ALND) without ILR, axillary lymph node dissection with ILR |
| measured by arm volumeBilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. If a patient cannot return to Manhattan for these assessments but is seen by a lymphedema therapist in a regional location or at an institution outside of MSK as part of their routine cancer treatment, this data can be used in the final analysis | Other | axillary lymph node dissection (ALND) without ILR, axillary lymph node dissection with ILR |
Primary outcome
the number of patients that had a decrease incidence of lymphedema
Time frame: up to 2 years
as measured by arm volume will be a ≥10% increase in arm volume
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Coriddi, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction, Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction and quality-of-life questionnaires in people with Breast Cancer Lymphedema, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients that had a decrease incidence of lymphedema (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.