Immediate Lymphatic Reconstruction for Breast Cancer Lymphedema

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byMichelle Coriddi, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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

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.

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Treatment Details

Interventions

Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction (Procedure)
Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction (Procedure)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: axillary lymph node dissection with ILRExperimental Treatment3 Interventions

Group II: axillary lymph node dissection (ALND) without ILRActive Control3 Interventions