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Tracking Information | |||||||||
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First Received Date † | October 6, 2005 | ||||||||
Last Updated Date | January 22, 2009 | ||||||||
Start Date † | September 2005 | ||||||||
Current Primary Outcome Measures † |
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer [ Time Frame: 36 months ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00235235 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||
Brief Title † | A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer | ||||||||
Official Title † | Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01 | ||||||||
Brief Summary | The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics. |
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Detailed Description | OUTLINE: This is a 4 arm, multi-center study. Sample Collection:
Treatment Regimens (Investigator/Patient Discretion):
Performance status & Organ Function: Performance status and organ function appropriate for chemotherapy in the opinion of the treating investigator according to Good Clinical Practice (GCP). Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: Not specified Pulmonary: Not specified |
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Study Phase | |||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Breast Cancer | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* 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 † | Recruiting | ||||||||
Enrollment † | 160 | ||||||||
Estimated Completion Date | December 2010 | ||||||||
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States, Peru | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00235235 | ||||||||
Responsible Party | Kathy Miller, M.D., Hoosier Oncology Group | ||||||||
Secondary IDs †† | Department of Defense BC030400 | ||||||||
Study Sponsor † | Hoosier Oncology Group | ||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | Hoosier Oncology Group | ||||||||
Verification Date | January 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |