Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

Study Overview
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Brief Summary
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This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

Detailed Description
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PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care. OUTLINE: This is a phase I study followed by a randomized phase II study. PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. After completion of study treatment, patients are followed up periodically.

Official Title
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Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: axillary lymph node dissection
* Drug: isosulfan blue based lymphatic mapping
* Procedure: axillary lymph node dissection
* Procedure: quality-of-life assessment
* Other: Questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer Exclusion Criteria: Prior lymphedema in either arm Prior history of axillary surgery (except for sentinel node biopsies) Prior history of chest/axillary radiation Need for bilateral axillary node dissection surgery Prior neurologic deficits (either motor or sensory) in ipsilateral arm Known allergy to vital blue dyes No prior diagnosis of inflammatory breast cancer Cannot be pregnant or planning to continue breast-feeding immediately after surgery
Sexes Eligible for Study
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Female

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (reverse mapping guided axillary lymph node dissection)<br>Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. | Procedure: axillary lymph node dissection<br>* Undergo reverse mapping-guided axillary lymph node dissection<br>* Other names: Lymphazurin blue dye;Drug: isosulfan blue based lymphatic mapping<br> <br> * Other names: Lymphazurin blue dye;Procedure: quality-of-life assessment<br>* Ancillary studies<br>Other: Questionnaire administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (control)<br>Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. | Drug: isosulfan blue based lymphatic mapping<br> <br> * Other names: Lymphazurin blue dye;Procedure: axillary lymph node dissection<br>* Undergo standard axillary lymph node dissection<br>* Other names: Lymphazurin blue dye;Procedure: quality-of-life assessment<br>* Ancillary studies<br>Other: Questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group. | Up to 4 years | 
| Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes | A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group. | Up to 4 years | 
| Percentage of Patients With Lymphedema | Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests. | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, axillary mapping, lymphedema