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A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer

NCT00058526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-05-15

No results posted yet for this 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

  • Neoplasms, Breast

Interventions

BIOLOGICAL

Immunotherapeutic SB719125 (Primary)

Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-20
Primary Completion
2006-09-06
Completion
2006-09-06

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00058526 on ClinicalTrials.gov