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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 15, 2009 | ||||||||
| Last Updated Date | January 13, 2010 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00903214 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer | ||||||||
| Official Title ICMJE | Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment | ||||||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | |||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00903214 | ||||||||
| Responsible Party | David H. Gorski, Barbara Ann Karmanos Cancer Institute | ||||||||
| Study ID Numbers ICMJE | CDR0000641180, WSU-2008-120 | ||||||||
| Study Sponsor ICMJE | Barbara Ann Karmanos Cancer Institute | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | January 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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