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Tracking Information | |||||
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First Received Date ICMJE | April 7, 2003 | ||||
Last Updated Date | September 27, 2006 | ||||
Start Date ICMJE | January 2003 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00058526 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer | ||||
Official Title ICMJE | A Multicenter Phase I Open-Label Dose-Escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-Overexpressing Patients With High-Risk Breast Cancer | ||||
Brief Summary | This trial will test how safe this vaccine is. It also tests whether its introduction induces an immune response by stimulating the patient's own immune system to recognize a specific target molecule called HER2, which is overexpressed in many breast cancers. The vaccine in this trial has not previously been administered to humans, and therefore the induction of the desired immune responses in humans remains to be established. Patients will receive 6 intramuscular vaccinations over a 14 week period, with 9 clinic visits and 3 follow up visits. In addition, patients are asked to revisit the study physician once a year for 5 years after the study ends to evaluate any long-term effects. |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Prevention, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety Study | ||||
Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Biological: Investigational Cancer Vaccine | ||||
Study Arms / Comparison Groups | |||||
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 ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 18 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 40 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Australia, Belgium, France, Italy | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00058526 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | 719125/002 | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | September 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |