Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Breast Neoplasms

Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

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

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

Undergo reverse mapping-guided axillary lymph node dissection

axillary lymph node dissection

isosulfan blue based lymphatic mapping

Undergo standard axillary lymph node dissection

quality-of-life assessment

Questionnaire administration

Steven Chen, MD

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.

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.

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

Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery

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.

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.

Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.

National Cancer Institute (NCI)

City of Hope Medical Center

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

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

axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection

isosulfan blue based lymphatic mapping

quality-of-life assessment: Ancillary studies

Questionnaire administration: Ancillary studies

Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)

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

isosulfan blue based lymphatic mapping

axillary lymph node dissection: Undergo standard axillary lymph node dissection

quality-of-life assessment: Ancillary studies

Questionnaire administration: Ancillary studies

Arm II (Control)

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

axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection

isosulfan blue based lymphatic mapping

quality-of-life assessment: Ancillary studies

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Study was terminated early due to loss of principal investigator. As a result accrual of subjects and data collection are incomplete.

Carolyn Behrendt, Ph.D.

Because of early termination the study did not accrue the planned number of subjects.

Spots Global Cancer Trial Database for axillary mapping