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Breast Diseases

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Vaccines

Adjuvants, Immunologic

Patients receive study vaccinations in 3 consecutive cycles:

* In Cycle 1 each patients will receive six vaccinations at two-week intervals followed by evaluation.
* In Cycle 2, subjects will patients six vaccinations at two-week intervals followed by evaluation.
* In Cycle 3, subjects will patients six vaccinations at three-week intervals.

Patients receive study vaccinations as second-line therapy

Patients receive six vaccinations at two-week intervals

GSK Biologicals' 719125

GSK Clinical Trials

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.

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.

Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer

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

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer	NCT00140738	Neoplasms, Brea...	GSK Biologicals...	18 Years -	GlaxoSmithKline
Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer	NCT00140738	Neoplasms, Brea...	GSK Biologicals...	18 Years -	GlaxoSmithKline
Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer	NCT00140738	Neoplasms, Brea...	GSK Biologicals...	18 Years -	GlaxoSmithKline

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