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NCT00058526 · ClinicalTrials.gov registry record · Phase 1
A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer
A Phase 1 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 17
- Study locations
NCT00058526 is a Phase 1 study of Neoplasms, Breast that has completed, run by GlaxoSmithKline. The registered enrollment target is 61 participants, below the 1,061-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (94% lower). The trial reports 17 study locations across 9 states.
The verdict
NCT00058526, a Phase 1 study of Neoplasms, Breast, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 17
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Immunotherapeutic SB719125 (Primary)
Study Locations (17)
Other
- GSK Investigational Site - Brussels
- GSK Investigational Site - Brussels
- GSK Investigational Site - Charleroi
- GSK Investigational Site - Leuven
- GSK Investigational Site - Lyon
- GSK Investigational Site - Paris
- GSK Investigational Site - Saint-Herblain
Victoria
- GSK Investigational Site - East Melbourne
- GSK Investigational Site - Footscray
- GSK Investigational Site - Heidelberg
Florida
- GSK Investigational Site - Boca Raton
New York
- GSK Investigational Site - Buffalo
North Carolina
- GSK Investigational Site - Charlotte
Washington
- GSK Investigational Site - Seattle
Lazio
- GSK Investigational Site - Rome
Lombardy
- GSK Investigational Site - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2003-03-20 |
| Est. Completion | 2006-09-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00058526
The ClinicalTrials.gov registry entry for NCT00058526 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,061-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (94% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 1 intervention - of which Immunotherapeutic SB719125 (Primary) is the first listed.
NCT00058526 reports 17 study locations spanning 9 distinct geographic areas - top geographies include Other, Victoria, Florida.
Frequently Asked Questions
What is clinical trial NCT00058526 about?
NCT00058526 is a clinical study titled "A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer". 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 c...
What is the current status of trial NCT00058526?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2003-03-20. Estimated completion is 2006-09-06.
What conditions does trial NCT00058526 study?
This clinical trial studies the following conditions: Neoplasms, Breast.
What interventions are being tested in trial NCT00058526?
The interventions under investigation include: Immunotherapeutic SB719125 (Primary) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00058526?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00058526 being conducted?
This trial has 17 study locations across Florida, New York, North Carolina, Washington, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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