Immediate Lymphatic Reconstruction for Breast Cancer Lymphedema

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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment Immediate Lymphatic Reconstruction for Breast Cancer Lymphedema?

Research shows that performing immediate lymphatic reconstruction (ILR) during axillary lymph node dissection (ALND) can reduce the risk of developing lymphedema (arm swelling due to lymph fluid buildup) in breast cancer patients. ^{1 2 3 4 5}

Is immediate lymphatic reconstruction safe for humans?

The available research focuses on the effectiveness of immediate lymphatic reconstruction (ILR) in reducing lymphedema (swelling due to lymph fluid buildup) after breast cancer surgery, but it does not provide specific safety data for humans. The studies primarily address concerns about cancer recurrence rather than general safety. ^{1 2 3 4 6}

How does the treatment of Immediate Lymphatic Reconstruction differ from other treatments for breast cancer lymphedema?

Immediate Lymphatic Reconstruction (ILR) is unique because it is performed at the same time as axillary lymph node dissection (ALND) to reduce the risk of developing lymphedema (arm swelling due to lymph fluid buildup), which is a common complication after breast cancer surgery. This approach aims to prevent lymphedema from occurring, unlike other treatments that typically address the condition after it has developed. ^{1 2 4 5 7}

Research Team

Michelle Coriddi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Immediate Lymphatic Reconstruction during Axillary Node Dissection for Breast Cancer: A Systematic Review and Meta-analysis. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Oncologic safety of axillary lymph node dissection with immediate lymphatic reconstruction. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Expanding Access to Immediate Lymphatic Reconstruction Through an Axillary Surgery Referral Program: A 6-Year Single-Center Experience. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Immediate Lymphatic Reconstruction after Axillary Lymphadenectomy: A Single-Institution Early Experience. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Propensity-Matched Analysis of the Influence of Breast Reconstruction on Subsequent Development of Lymphedema. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Is Immediate Lymphatic Reconstruction on Breast Cancer Patients Oncologically Safe? A Preliminary Study. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Quantifying radiation in the axillary bed at the site of lymphedema surgical prevention. [2023]