Spots Global Cancer Trial Database for Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer
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Trial Identification
Brief Title: Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer
Official Title: A Multicenter, Open-label Phase I/II Trial of the Safety and Efficacy of the dHER2 Recombinant Protein Combined With Immunological Adjuvant AS15 in Patients With Metastatic Breast Cancer Overexpressing HER2/Neu
Study ID: NCT00140738
Conditions
Interventions
Study Description
Brief Summary: Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.
Detailed Description: This Phase I/II study will be conducted according to a multicenter, open-label design. At least 20 patients will receive the vaccine as first-line and at least 20 as second-line treatment. The treatment will comprise a maximum of 18 injections of dHER2 vaccine. Follow-up phase: This will commence with the end-of-treatment examination, followed by examinations three months, six months and twelve months after the last study vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
GSK Investigational Site, Charleroi, , Belgium
GSK Investigational Site, Hasselt, , Belgium
GSK Investigational Site, Ottignies, , Belgium
GSK Investigational Site, Bogotá, , Colombia
GSK Investigational Site, Lyon Cedex 08, , France
GSK Investigational Site, Montpellier Cedex 5, , France
GSK Investigational Site, Paris Cedex 05, , France
GSK Investigational Site, Saint-Cloud, , France
GSK Investigational Site, Saint-Herblain, , France
GSK Investigational Site, Toulouse cedex, , France
GSK Investigational Site, Vandoeuvre-Les-Nancy, , France
GSK Investigational Site, Roma, Lazio, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Lima, , Peru
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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