Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer
NCT00343109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2020-02-12
Summary
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Conditions
- HER2-positive Breast Cancer
- Male Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Stage IV Breast Cancer
Interventions
- BIOLOGICAL
-
HER-2/neu intracellular domain protein
Given ID
- PROCEDURE
-
leukapheresis
Optional correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
- BIOLOGICAL
-
sargramostim
Given ID
- OTHER
-
immunologic technique
Correlative studies
- BIOLOGICAL
-
synthetic tumor-associated peptide vaccine therapy
Given ID
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Mary Disis · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2015-06-30
Countries
- United States
Study Locations
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