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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00058526 |
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: | Prevention, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety Study |
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 |
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, California | |
Study Site | |
Greenbrae, California, United States, 94904 | |
United States, Florida | |
Study Site | |
Hollywood, Florida, United States, 33324 | |
Study Site | |
Plantation, Florida, United States, 33324 | |
United States, Kentucky | |
Study Site | |
Louisville, Kentucky, United States, 40202 | |
United States, Minnesota | |
Study Site | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Study Site | |
Buffalo, New York, United States, 14263 | |
United States, North Carolina | |
Study Site | |
Charlotte, North Carolina, United States, 28203 | |
United States, Pennsylvania | |
Study Site | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Washington | |
Study Site | |
Seattle, Washington, United States, 98195 | |
Australia, Victoria | |
Study Site | |
Footscray, Victoria, Australia, VIC 3011 | |
Study Site | |
Parkville, Victoria, Australia, VIC 3050 | |
Study Site | |
Heidelberg, Victoria, Australia, VIC 3084 | |
Study Site | |
East Melbourne, Victoria, Australia, VIC 3002 | |
Belgium | |
Study Site | |
Brussels, Belgium, B-1000 | |
Study Site | |
Leuven, Belgium, B-3000 | |
Study Site | |
Brussels, Belgium, B-1200 | |
Study Site | |
Leuven, Belgium, B-3000 | |
Belgium, Hainaut | |
Study Site | |
Charleroi, Hainaut, Belgium, B-6000 | |
France | |
Study Site | |
Nantes-St-Herblain, France, F-44805 | |
Study Site | |
Lyon Cedex 08, France, F-69 373 | |
Study Site | |
Paris Cedex 05, France, F-75 248 | |
Italy | |
Study Site | |
Perugia, Italy, I-06122 | |
Study Site | |
Roma, Italy, I-00161 | |
Study Site | |
Milano, Italy, I-20141 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study ID Numbers: | 719125/002 |
Study First Received: | April 7, 2003 |
Last Updated: | September 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00058526 |
Health Authority: | United States: Food and Drug Administration |
dHER-AS15-002 |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |