A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

April 7, 2003

Last Updated Date

September 27, 2006

Start Date ^ICMJE

January 2003

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00058526 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Biological: Investigational Cancer Vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, France, Italy

Expanded Access Status

Administrative Information

NCT ID ^ICMJE

NCT00058526

Responsible Party

Study ID Numbers ^ICMJE

719125/002

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2006

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