Trial Information

Sentinel Lymph Node Biopsy in the Assessment of Axillary Nodal Status in Operable Breast Cancer

OBJECTIVES:

- Compare sentinel node biopsy vs axillary dissection in determining axillary nodal
status in women with resectable stage I or II breast cancer.

OUTLINE: Patients are stratified according to node status (positive vs negative).

Patients undergo lymphoscintigraphy, which consists of technetium Tc 99m human serum albumin
colloid being injected near the tumor. Dynamic imaging using a gamma camera is performed for
20 minutes postinjection and static images are obtained for up to 3 hours postinjection.

Surgery is performed within 24 hours of lymphoscintigraphy. Patients are injected with
patent blue V dye near the tumor and a gamma detection probe is used to measure radioactive
counts in the sentinel node. Surgery begins within 5 minutes of the patent blue V dye
injection.

All lymph nodes that stain blue or have a high radioactive count are removed. The primary
breast lump is removed by either wide local excision or mastectomy and the axilla are
cleared by standard axillary dissection.

Some patients may only receive patent blue V dye injected as a pilot study. Sentinel lymph
node biopsy and axillary dissection proceed as above.

PROJECTED ACCRUAL: A total of 150 patients (75 per stratum) will be accrued for the main
study plus another 50 patients for the pilot study.