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Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment



- 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.


- 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

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.

Inclusion Criteria


- Diagnosis of adenocarcinoma of the breast

- Stage I (T1c)-IIIA disease meeting the following criteria:

- Large enough (> 1 cm) to undergo additional multiple core needle biopsies

- Surgically resectable for cure or palliation without first requiring
neoadjuvant chemotherapy

- Patients who have previously been treated for breast cancer, but are judged to have
developed a new primary cancer, rather than a recurrence, are eligible


- ECOG performance status 0-1

- ANC ≥ 1,000/mm³

- Platelet count ≥ 50,000/mm³

- Liver function tests ≤ 3 times upper limit of normal (ULN)

- Total bilirubin ≤ 2 times ULN

- Creatinine ≤ 1.5 mg/dL

- INR ≤ 25% normal limits

- Not pregnant or nursing

- No known history of HIV or AIDS

- No known history of hepatitis B or C

- No history of vertigo or Ménière's type of disorder

- No history of allergic reaction to riluzole or similar compounds


- No prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or
surgery for the treatment of breast cancer

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity

Outcome Time Frame:

Pre and Post-treatment with RILUTEK® (riluzole) administration

Safety Issue:


Principal Investigator

David H. Gorski, MD, PhD, FACSw

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms