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A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer
NCT00058526 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00058526 reports 17 study locations spanning 9 distinct geographic areas — top geographies include Other, Victoria, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00058526?
The interventions under investigation include: Immunotherapeutic SB719125 (Primary) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00058526?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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