Full Text View
Tabular View
No Study Results Posted
Related Studies
A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer
This study is ongoing, but not recruiting participants.
Study NCT00058526   Information provided by GlaxoSmithKline
First Received: April 7, 2003   Last Updated: September 27, 2006   History of Changes

April 7, 2003
September 27, 2006
January 2003
 
 
Complete list of historical versions of study NCT00058526 on ClinicalTrials.gov Archive Site
 
 
 
A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer
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

This trial will test how safe this vaccine is. It also tests whether its introduction induces an immune response by stimulating the patient's own immune system to recognize a specific target molecule called HER2, which is overexpressed in many breast cancers.

The vaccine in this trial has not previously been administered to humans, and therefore the induction of the desired immune responses in humans remains to be established. Patients will receive 6 intramuscular vaccinations over a 14 week period, with 9 clinic visits and 3 follow up visits. In addition, patients are asked to revisit the study physician once a year for 5 years after the study ends to evaluate any long-term effects.

 
Phase I
Interventional
Prevention, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety Study
Breast Cancer
Biological: Investigational Cancer Vaccine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
18
 
 

Inclusion criteria:

  • Provide written informed consent.
  • Previous diagnosis of HER2/neu-positive breast cancer.
  • Stage II with 4 or more positive nodes, or Stage III in remission.
  • Have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment with or without local-regional breast irradiation.
  • Free of recurrent breast cancer disease.
  • Current chest X-ray showing no evidence of disease.
  • Completed at least one course of standard adjuvant treatment within 2 years of study entry.
  • Life expectancy of at least 12 months.

Exclusion criteria:

  • Surgery or chemotherapy treatment within 8 weeks of study enrollment.
  • Radiotherapy within 12 weeks of study enrollment.
  • Use of other experimental agents during study.
  • Use of investigational or commercial agents or therapies intended to treat the malignancy during the study or within 1 month prior to first study vaccination.
  • Patients younger than 40 years of age must be sterile or incapable of childbearing.
  • Heart problems or uncontrolled hypertension, bleeding or coagulation disorders, auto-immune disorders, or psychiatric illness or addictive disorders.
  • Known to be HIV positive.
  • Past or current treatment with drug Herceptin.
  • Pregnant or breastfeeding.
  • Any uncontrolled illness that would preclude the study.
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   France,   Italy
 
 
NCT00058526
 
719125/002
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP