Trial Information

French Randomized Sentinel Node Multicentric Study

OBJECTIVES:

- Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V
dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer
undergoing sentinel lymph node identification.

- Determine the reduction of morbidity associated with breast cancer surgery, in terms of
local control and survival, in patients undergoing sentinel lymph node identification
with these drugs.

- Determine the evolution of disease in patients who have undergone this procedure and do
not show histological invasion of the sentinel lymph node.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc
99m sulfur colloid.

- Arm II: Patients receive periareolar injections as in arm I. Patients in both arms
showing histological metastasis of the sentinel lymph node or without identification of
the sentinel lymph node undergo standard axillary lymph node dissection.

Patients are followed for disease evolution.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study
within 2-2.5 years.