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

This study has been completed.

First Received on April 7, 2003. Last Updated on November 10, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00058526

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Biological: Investigational Cancer Vaccine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	18
Study Start Date:	March 2003

Intervention Details:

Other Name: Investigational Cancer Vaccine

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058526

Locations

United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33428
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14263
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98195
Australia, Victoria
GSK Investigational Site
Footscray, Victoria, Australia, 3011
GSK Investigational Site
Heidelberg, Victoria, Australia, 3084
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Charleroi, Belgium, 6000
GSK Investigational Site
Leuven, Belgium, 3000
France
GSK Investigational Site
Lyon Cedex 08, France, 69373
GSK Investigational Site
Paris Cedex 5, France, 75248
GSK Investigational Site
Saint-Herblain, France, 44805
Italy
GSK Investigational Site
Milano, Lombardia, Italy, 20141
GSK Investigational Site
Perugia, Umbria, Italy, 06156

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00058526 History of Changes
Other Study ID Numbers:	719125/002
Study First Received:	April 7, 2003
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

dHER-AS15-002

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012