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

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Procedure: axillary lymph node dissection; Drug: isosulfan blue based lymphatic mapping; Procedure: quality-of-life assessment; Other: Questionnaire administration

• Registration Number: NCT00932035
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-30
• Study First Posted: 2009-07-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2016-12-09
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-05
• Last Update Submitted: 2017-05-05
• Results First Posted: 2017-06-07
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (reverse mapping guided axillary lymph node dissection)	axillary lymph node dissection	Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
Arm I (reverse mapping guided axillary lymph node dissection)	isosulfan blue based lymphatic mapping	Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
Arm II (control)	isosulfan blue based lymphatic mapping	Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
Arm II (control)	axillary lymph node dissection	Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
Arm II (control)	quality-of-life assessment	Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
Arm I (reverse mapping guided axillary lymph node dissection)	quality-of-life assessment	Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
Arm I (reverse mapping guided axillary lymph node dissection)	Questionnaire administration	Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
Arm II (control)	Questionnaire administration	Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein	Up to 4 years	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.
Percentage of Patients With Lymphedema	Up to 4 years	Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.
Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes	Up to 4 years	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.

Trial Locations

Locations (3)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States