Phase 2
Completed N=31
Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy
HER2/Neu Positive · Breast Cancer · Stage IV Breast Cancer
Source: ClinicalTrials.gov NCT01922921 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Number of Patients With Grade 3 or Higher Toxicity Per Study Arm. — 2; 0 Participants
Summary
This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain (ICD) peptide may help the body build an effective immune response to kill tumor cells that express HER2. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy works better when given with or without polysaccharide-K in treating breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Grade 3 or Higher Toxicity Per Study Arm. |
2; 0 | — |
| SECONDARY Induction of Interferon (IFN)-Gamma Production and Cluster of Differentiation (CD)107a Expression in NK Cells, Via Flow Cytometry |
4; 9; 4; 7; 5; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with stage IV HER2+ breast cancer treated to:
- No evidence of disease (NED), or
- Stable bone only disease after definitive therapy
- HER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in the primary tumor or metastasis; or documented gene amplification by fluorescent in situ hybridization (FISH) analysis; IHC = = 3000/mm^3
- Hemoglobin (Hgb) >= 10 g/dl
- Serum creatinine = 60 ml/min
- Total bilirubin = = the lower limit of normal for the facility on multi gated acquisition (MUGA) scan or echocardiogram (ECHO) within 3 months of enrollment
Exclusion Criteria
- Patients with any of the following cardiac conditions:
- Restrictive cardiomyopathy
- Unstable angina within 6 months prior to enrollment
- New York Heart Association functional class III-IV heart failure
- Symptomatic pericardial effusion
- Patients with any contraindication to receiving rhu granulocyte macrophage colony stimulating factor (rhuGM-CSF) based products
- Patients with any clinically significant autoimmune disease requiring active treatment
- Patients receiving any concurrent immunosuppressants
- Patients who are pregnant or breast-feeding
- Patients who are simultaneously enrolled in other treatment studies
- Patients who have received a previous HER2 breast cancer vaccine
- Known hypersensitivity reaction to mushroom products
Data sourced from ClinicalTrials.gov (NCT01922921). 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.