An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction

Study Overview
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Brief Summary
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This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.

Detailed Description
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PRIMARY OBJECTIVE: I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction. SECONDARY OBJECTIVES: I. Determine the overall complications of prophylactic vascularized lymph node transfers. II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer. OUTLINE: Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery. After completion of study, patients are followed up for 3 weeks, at 3 and 6 months, and then at 1 and 2 years.

Official Title
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Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous Breast Reconstruction

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Procedure: Mammoplasty
* Procedure: Vascularized Lymph Node Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction Exclusion Criteria: Patients that are known to be pregnant at the time of surgery Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (vascularized lymph node transfer)<br>Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery. | Procedure: Mammoplasty<br>* Undergo standard of care breast reconstructive surgery<br>* Other names: Breast Reconstruction;Procedure: Vascularized Lymph Node Transfer<br>* Undergo vascularized lymph node transfer<br>* Other names: VLNT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of lymphedema development | Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated. | At 12 months after surgery | 
| Time to lymphedema development | Will be estimated by the Kaplan-Meier method. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of lymphedema development | The incidence of lymphedema between patients who undergo vascularized lymph node transfer (VLNT) and historical cohorts who do not will be compared. The inverse probability of treatment weighting using the propensity scores will be applied to estimate the effect of VLNT. | Up to 2 years | 
| Complications of prophylactic VLNT | Overall complications will include infections, dehiscence, hematoma, seroma and flap compromises. The 95% exact confidence interval will be estimated. | Within 30 days after surgery |