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

City of Hope

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Other: Questionnaire administration; Drug: isosulfan blue based lymphatic mapping; Procedure: quality-of-life assessment; Procedure: axillary lymph node dissection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00932035

11130 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups

Arm I (reverse mapping guided axillary lymph node dissection)

Experimental group

Description:

Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.

Treatment:

Procedure: axillary lymph node dissection

Procedure: axillary lymph node dissection

Procedure: quality-of-life assessment

Drug: isosulfan blue based lymphatic mapping

Other: Questionnaire administration

Arm II (control)

Active Comparator group

Description:

Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

Treatment:

Procedure: axillary lymph node dissection

Procedure: axillary lymph node dissection

Procedure: quality-of-life assessment

Drug: isosulfan blue based lymphatic mapping

Other: Questionnaire administration