Clinical trial · Interventional
Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer
Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment
NCT00903214CI-TRIAL-00010149withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding ended
Summary
Brief summary (as posted)
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the growth of tumor cells. PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage IIIA breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axillary lymph node biopsy | Procedure | — | UNRESOLVED |
| digital image analysis | Procedure | — | UNRESOLVED |
| needle biopsy | Procedure | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
| riluzole | Drug | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity
- timeFrame
- Pre and Post-treatment with RILUTEK® (riluzole) administration
- measure
- Downregulation of phosphorylated ERK1/2
- timeFrame
- Pre and Post treatment with RILUTEK® (riluzole) administration:
Secondary outcomes (2)
- measure
- Measures of proliferation, specifically mitotic rate and expression of Ki-67
- timeFrame
- Pre and Post treatment with RILUTEK® (riluzole) administration:
- measure
- Measures of apoptosis, specifically levels of poly(ADP-ribose) polymerase (PAPR) cleavage and caspase III activity
- timeFrame
- Pre and Post treatment with RILUTEK® (riluzole) administration:
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* 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 preoperatively
* 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
PATIENT CHARACTERISTICS:
* 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
PRIOR CONCURRENT THERAPY:
* No prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or surgery for the treatment of breast cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.