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

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.

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