Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140738
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2005-08-31
Brief Title:
Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicenter Open-label Phase III Trial of the Safety and Efficacy of the dHER2 Recombinant Protein Combined With Immunological Adjuvant AS15 in Patients With Metastatic Breast Cancer Overexpressing HER2Neu
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-001120-20 | EUDRACT_NUMBER | None | None |