Phase 1
Completed N=32
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
HER2/Neu Negative · No Evidence of Disease · One or More Positive Axillary Nodes · Stage IB Breast Cancer
Source: ClinicalTrials.gov NCT02780401 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 — 45; 53; 30; 2 Count of Related Adverse Events per Arm
Summary
This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0 |
45; 53; 30; 2; 1; 7 | — |
| SECONDARY Assessment of IgG Antibodies |
— | — |
| SECONDARY Assessment of T Helper Th1:Th2 Ratio |
3.5; 4.5; 1.2 | — |
| SECONDARY Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells |
92; 109; 402; 639; 203; 237.5 | — |
| SECONDARY Level of Antigen Specific Central and Effector Memory Phenotypes (Persistent Memory T Cell Response) |
— | — |
| SECONDARY Modulation of Myeloid Derived Suppressor Cell Levels |
0.00; 0.00; 0.01 | — |
| SECONDARY Modulation of T Regulatory Cell Levels |
8; 5; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as
- 0-1+ HER2 expression by immunohistochemistry (IHC) OR
- Fluorescence in situ hybridization (FISH) negative OR
- HER2 2+ and FISH negative
- Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy administered during the study are eligible and may continue throughout duration of study
- Patients must be at least 28 days post systemic steroids prior to enrollment
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of = = 3000/mm^3
- Hemoglobin (Hgb) >= 10 g/dl
- Lymphocyte count >= 800/mm^3
- Platelet count >= 75,000/mm^3
- Serum creatinine = 60 ml/min
- Total bilirubin = = lower limit of normal (LLN) for institution performing based on results from the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done at baseline
- Willing to not undergo any elective surgical procedure with general anesthesia or conscious sedation through the 1 month post-vaccination visit
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Patients with any of the following cardiac conditions:
- Symptomatic restrictive cardiomyopathy
- Dilated cardiomyopathy
- Unstable angina within 4 months prior to enrollment
- New York Heart Association functional class III-IV heart failure on active treatment
- Symptomatic pericardial effusion
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to WOKVAC
- Patients with any contraindication or known hypersensitivity to receiving sargramostim (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products
- Pregnant women are excluded from this study because WOKVAC is a vaccine agent with unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with WOKVAC breastfeeding should be discontinued if the mother is treated with this vaccine
- History of diabetes
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- History of autoimmunity that has not been controlled with treatment in the last 12 months
Data sourced from ClinicalTrials.gov (NCT02780401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.