A Phase 1/2 interventional study of HER-2/neu Peptide Vaccine and Laboratory Biomarker Analysis in HER2/Neu Positive, HLA-A2 Positive Cells Present and Stage IV Breast Cancer, sponsored by University of Washington. Completed at 1 site in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by University of Washington · Phase 1/2, Interventional, and Treatment
This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides may help increase HER2 specific immunity and immune memory cells.
PRIMARY OBJECTIVES:
I. To evaluate the safety of administering a HER2 cytotoxic T-cell (CTL) peptide-based vaccine (HER-2/neu peptide vaccine) to stage IV breast and ovarian cancer patients receiving maintenance trastuzumab.
II. To quantify and characterize antigen specific T cell subsets specific to HER2 in peripheral blood mononuclear cell (PBMC) of patients after vaccination with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.
SECONDARY OBJECTIVES:
I. To evaluate overall survival (OS) in patients who complete a vaccination series with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.
OUTLINE:
Patients receive HER-2/neu peptide vaccine intradermally (ID) once per month for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then yearly for up to 5 years.
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Exclusion Criteria:
Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.
Biological: HER-2/neu Peptide Vaccine · Other: Laboratory Biomarker Analysis
Given ID
Also known as: HER-2-Neu Peptide Vaccine, HER-2/neu Helper-Peptide Vaccine
Correlative studies
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis
ELIspot: Increased immune response is defined as spots per well (SPW) greater than 2 standard deviations (SD) above baseline value, remained the same if the mean SPW was within 2 SD of the previous value, or decreased if the mean SPW was greater than 2 SD below the previous value. Two SD is equivalent to a P value of .05 in that there is a 95% probability that the values are statistically significant. T is reported as percentage of patients and their corresponding results. HLA-A2 Major Histocompatibility Complex Tetramer Analysis is evaluated using a non-radioactive assay for cell lysis. The HLA-A2 transfected human HER2/neu expressing breast cancer cell line, SKBR3-A2 T cells, expanded after stimulation with immunizing peptide, were added in an effector/target ratio of 40:1. Percent specific lysis was calculated as: (\[experimental release-spontaneous releases of cytotoxic T-lymphocyte cells and target cells\]/\[maximum release-spontaneous release of target cells\])X100.
Time frame: Up to 1.5 years (12 months following the last vaccination)
Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
Descriptive statistics will be used to summarize changes from baseline. At the point the participant signs consent and before they start vaccine we record their existing baseline events (symptoms and diagnoses) and assign a grade to them (see below). Once a participant starts vaccine treatment adverse event AEs were recorded if they are new to the participant or if they increased in severity over their baseline. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Time frame: Up to 7 months (30 days following the last vaccination)
Overall Survival
Survival for the Stage IV breast cancer patients will be compared to historical control.
Time frame: Up to 5 years
| Milestone | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| Started | 22 |
| Completed | 21 |
| Not completed | 1 |
ELIspot: Increased immune response is defined as spots per well (SPW) greater than 2 standard deviations (SD) above baseline value, remained the same if the mean SPW was within 2 SD of the previous value, or decreased if the mean SPW was greater than 2 SD below the previous value. Two SD is equivalent to a P value of .05 in that there is a 95% probability that the values are statistically significant. T is reported as percentage of patients and their corresponding results. HLA-A2 Major Histocompatibility Complex Tetramer Analysis is evaluated using a non-radioactive assay for cell lysis. The HLA-A2 transfected human HER2/neu expressing breast cancer cell line, SKBR3-A2 T cells, expanded after stimulation with immunizing peptide, were added in an effector/target ratio of 40:1. Percent specific lysis was calculated as: (\[experimental release-spontaneous releases of cytotoxic T-lymphocyte cells and target cells\]/\[maximum release-spontaneous release of target cells\])X100.
| Participants | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| HLA-A2 Results — Significantly augmented immune response | 14 |
| HLA-A2 Results — Did not have augmentation of immune response | 4 |
| HLA-A2 Results — Decrease in immune response | 1 |
| ELIspot — Significantly augmented immune response | 16 |
| ELIspot — Did not have augmentation of immune response | 3 |
| ELIspot — Decrease in immune response | 0 |
Descriptive statistics will be used to summarize changes from baseline. At the point the participant signs consent and before they start vaccine we record their existing baseline events (symptoms and diagnoses) and assign a grade to them (see below). Once a participant starts vaccine treatment adverse event AEs were recorded if they are new to the participant or if they increased in severity over their baseline. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
| adverse events | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| Grade 1 | 508 |
| Grade 2 | 60 |
| Grade 3 | 4 |
| Grade 4 | 1 |
Survival for the Stage IV breast cancer patients will be compared to historical control.
| Participants | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| Alive | 10 |
| Deceased | 11 |
Collected over Patients were evaluated during the study treatment (6 months) and then for 5 additional years after that where we were evaluating any potential development of long-term autoimmune disease.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (HER-2/Neu Peptide Vaccine) | 11/21 (52.4%) | 3/21 (14.3%) | 21/21 (100%) |
| Event | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| CNS Cerebrovascular IschemaNervous system disorders | 1/21 |
| Cardiac ArrhythmiaCardiac disorders | 1/21 |
| UlcerationSkin and subcutaneous tissue disorders | 1/21 |
| Event | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| FatigueGeneral disorders | 20/21 |
| Injection Site ReactionGeneral disorders | 20/21 |
| Pain - HeadacheNervous system disorders | 14/21 |
| MyalgiaMusculoskeletal and connective tissue disorders | 13/21 |
| Rigors/ChillsGeneral disorders | 12/21 |
| Pruritis/ItchingSkin and subcutaneous tissue disorders | 12/21 |
| NauseaGastrointestinal disorders | 12/21 |
| DiarrheaGastrointestinal disorders | 11/21 |
| LymphopeniaInvestigations | 10/21 |
| LeukopeniaInvestigations | 10/21 |
| Age, Categorical(Participants) | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 2 |
| Age, Continuous(years) | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| Median | 49 (33 to 76) |
| Sex: Female, Male(Participants) | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| Female | 21 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (HER-2/Neu Peptide Vaccine) |
|---|---|
| United States | 21 |
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