Immediate Lymphatic Reconstruction for Breast Cancer Lymphedema

Not currently recruiting at 9 trial locations

Overseen By Babak Mehrara, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Male, Non-English, Axillary recurrence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether immediate lymphatic reconstruction, a surgical procedure to restore lymph flow, performed right after axillary lymph node dissection (ALND), can reduce the risk of lymphedema, a common side effect that causes swelling. It compares the outcomes of immediate reconstruction with ALND alone. The trial also investigates whether adding standard radiation therapy affects lymphedema development. Women with breast cancer who plan to undergo ALND and have a positive lymph node might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that immediate lymphatic reconstruction (ILR) after removing lymph nodes in the underarm area is generally safe. Studies have found that this procedure does not cause cancer to return in the short term, meaning it doesn't increase cancer risk.

The technique is considered safe and effective. Evidence indicates it significantly lowers the chance of developing lymphedema, which is swelling from lymph fluid build-up. Specifically, the risk of lymphedema is about half for patients who undergo ILR compared to those who do not.

Overall, the data suggest that ILR is well-tolerated and helps prevent lymphedema without increasing cancer-related risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Immediate Lymphatic Reconstruction (ILR) for breast cancer lymphedema because it offers a proactive approach right at the time of axillary lymph node dissection. Traditional treatments for lymphedema, like compression garments and physical therapy, focus on managing symptoms after they occur. Unlike these options, ILR aims to prevent lymphedema from developing in the first place by reconstructing lymphatic pathways immediately during surgery. This innovative technique potentially reduces the long-term complications and discomfort associated with lymphedema, offering a better quality of life for patients.

What evidence suggests that immediate lymphatic reconstruction after axillary lymph node dissection could be effective for reducing lymphedema?

Research has shown that immediate lymphatic reconstruction (ILR) performed right after removing lymph nodes in the armpit area (a procedure known as axillary lymph node dissection, or ALND) can significantly reduce the risk of breast cancer-related lymphedema. In this trial, one group of participants will receive ALND with ILR, which studies have found reduces the risk of lymphedema by about half. This substantial reduction indicates that ILR is quite effective. Meanwhile, another group will undergo ALND without ILR, which carries a high risk of lymphedema, affecting 30% to 50% of patients. These findings suggest that ILR after ALND can help prevent lymphedema. ^{1 2 6 7 8}

Who Is on the Research Team?

Michelle Coriddi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree to have lymph node surgery and may have had a sentinel lymph node biopsy less than 6 months ago.

I am a woman aged 18-75 with breast cancer.

My surgery will involve connecting a lymph channel and a vein.

Exclusion Criteria

I am a woman with breast cancer and have had lymph nodes removed.

I need both sides of my lymph nodes removed due to breast cancer.

I had a sentinel lymph node biopsy for breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo axillary lymph node dissection with or without immediate lymphatic reconstruction, and may receive standard of care radiation therapy

6-8 weeks

Follow-up

Participants are monitored for the development of lymphedema and quality of life improvements

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
• Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction

Trial Overview

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.

How Is the Trial Designed?

Group I: axillary lymph node dissection with ILR Experimental Treatment 3 Interventions

Group II: axillary lymph node dissection (ALND) without ILR Active Control 3 Interventions

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 11 breast cancer patients who underwent immediate lymphatic reconstruction (ILR) and received adjuvant radiation therapy, 64% had their ILR site within the radiation field, receiving a median dose of 4280 cGy, which raises concerns about the risk of lymphedema.

Even for patients whose ILR sites were outside the planned radiation fields, they still received some radiation exposure (median dose of 233 cGy), indicating a need for strategies to minimize radiation to these critical areas during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying radiation in the axillary bed at the site of lymphedema surgical prevention. Friedman, R., Spiegel, DY., Kinney, J., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12222251/

Long-Term Outcomes of Lymphedema After Immediate ...

Despite advancements in breast cancer therapies and surgical techniques, the risk of developing lymphedema is 30% to 50% after axillary lymph ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0748798324014458

The efficacy of immediate lymphatic reconstruction after ...

In this meta-analysis, performing ILR achieves an overall reduction of relative risk for BCRL. Immediate lymphatic reconstruction decreases the risk of BCRL.

3.

medicaljournalssweden.se

medicaljournalssweden.se/JPHS/article/view/43738/50854

View of The efficacy of immediate lymphatic reconstruction ...

The primary aim of this study was to compare the risk of lymphedema between the ILR and control groups in patients who underwent axillary lymph node dissection ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12381909/

Efficacy of Immediate Lymphatic Reconstruction in ...

Axillary lymph node dissection (ALND) and adjuvant radiation therapy are major risk factors for postoperative upper extremity breast cancer‐ ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S235258782500066X

Immediate lymphatic reconstruction for breast cancer ...

This systematic review revealed an overall relative risk (RR) of 0.51 of developing BCRL in patients receiving ILR after axillary lymph node dissection. The RR ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36239840/

Oncologic safety of axillary lymph node dissection with ...

Conclusion: Immediate lymphatic reconstruction in patients with breast cancer undergoing ALND is not associated with short term axillary recurrence and appears ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04241341?term=NCT04241341&rank=1

Does Immediate Lymphatic Reconstruction Decrease the ...

... Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection. Conditions. Breast Cancer Lymphedema. Breast ...

8.

jprasurg.com

jprasurg.com/article/S1748-6815(24)00771-X/fulltext

Immediate lymphatic reconstruction with targeted ...

TLAR is shown to be a safe, effective, and physiologic technique for reducing lymphedema risk in patients with breast cancer.