Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer

OBJECTIVES:

Primary

- To evaluate the effects of glutamate receptor blockade with riluzole on cellular
pathways important in the genesis and progression of disease in women with stage I-IIIA
breast cancer by examining components of the mGluR1 signaling pathway in the pre- and
post-treatment tumor samples to determine if glutamate blockade affects signaling
through this pathway.

Secondary

- To determine whether treatment with riluzole affects the proliferation and apoptosis in
a manner suggesting a potential for therapeutic effectiveness.

- To determine whether treatment with riluzole causes objectively measurable tumor
shrinkage.

OUTLINE: Patients receive oral riluzole twice daily on days -14 to 0. Approximately 12 hours
after completion of riluzole therapy patients undergo standard surgery (i.e., partial or
total mastectomy) along with sentinel lymph node biopsy (for patients with node-negative
disease) or full axillary dissection (for patients with node-positive disease) on day 0.

Patients undergo 3-dimensional image assessment at pre- and post-treatment by Computerized
Ultrasound Risk Evaluation (C.U.R.E.).

Patients undergo core needle biopsy at baseline and during surgery for biomarker analysis
(e.g., mGluR1) by IHC, western blotting, and RT-PCR. Blood samples are collected for GRM1
polymorphism analysis.

After completion of study treatment, patients are followed every 6 months for 1 year and
then according to standard-of-care thereafter.