Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058526
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2003-04-07
Brief Title:
A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Treatment phase
The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15 The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product
Five-year follow-up phase
This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients survival and disease status up to five years after the last administration of the study treatment The patients immune response is also measured to assess the robustness of the immune response elicited by the study treatment
The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15 The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product
Five-year follow-up phase
This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients survival and disease status up to five years after the last administration of the study treatment The patients immune response is also measured to assess the robustness of the immune response elicited by the study treatment
Detailed Description:
None
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 |
|---|---|---|---|
| 104482 | OTHER | GlaxoSmithKline | None |