Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy
Status and phase
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Treatments
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Details and patient eligibility
About
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.
Full description
PRIMARY OBJECTIVES:
I. To evaluate the safety of polysaccharide-K (PSK) when given with HER2-directed immunotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the effect of PSK on natural killer (NK) cell functional activity when given with HER2-directed immunotherapy.
TERTIARY OBJECTIVES:
I. To investigate the effect of PSK when given with HER2-directed immunotherapy on: serum levels of pro-inflammatory cytokine and/or chemokines; intermolecular epitope spreading; serum transforming growth factor (TGF)-beta levels; progression free survival (PFS) and overall survival (OS).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive HER2 ICD peptide-based vaccine intradermally (ID) once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo orally (PO) twice daily (BID) for 4 months.
ARM II: Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab (or trastuzumab and pertuzumab) as in Arm I and polysaccharide-K PO BID for 4 months.
After completion of study treatment, patients are followed up for 9 months and then twice annually for 3 years.
Enrollment
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Volunteers
Inclusion criteria
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Patients with stage IV HER2+ breast cancer treated to:
- No evidence of disease (NED), or
- Stable bone only disease after definitive therapy
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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 =< 2+ must have HER2 gene amplification documented by FISH
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Patients must continue HER2-targeted monoclonal antibody therapy dosing per standard of care through the entire study period (one year)
- HER2-targeted monoclonal antibody therapy is defined as either trastuzumab monotherapy, or trastuzumab and pertuzumab combination therapy administered per standard of care
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Patients must be at least 21 days post cytotoxic chemotherapy prior to enrollment
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Patients must be at least 28 days post immunosuppressants prior to enrollment
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Patients must be at least 28 days from use of any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake) and agree to withhold them for the entire study period (one year)
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Patients on bisphosphonates and/or endocrine therapy are eligible
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Patients who are having sex that could lead to pregnancy must agree to contraceptive use during the entire study period
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Patients must have Zubrod performance status score of =< 2
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Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have significant active concurrent medical illnesses precluding study treatment
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White blood cell (WBC) >= 3000/mm^3
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Hemoglobin (Hgb) >= 10 g/dl
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Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
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Total bilirubin =< 1.5 mg/dl
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Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times the upper limit of normal
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Patients must have adequate cardiac function as demonstrated by normal left ventricular ejection fraction (LVEF) >= the lower limit of normal for the facility on multi gated acquisition (MUGA) scan or echocardiogram (ECHO) within 3 months of enrollment
Exclusion criteria
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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
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Patients with any contraindication to receiving rhu granulocyte macrophage colony stimulating factor (rhuGM-CSF) based products
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Patients with any clinically significant autoimmune disease requiring active treatment
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Patients receiving any concurrent immunosuppressants
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Patients who are pregnant or breast-feeding
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Patients who are simultaneously enrolled in other treatment studies
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Patients who have received a previous HER2 breast cancer vaccine
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Known hypersensitivity reaction to mushroom products
Trial design
Primary purpose
Allocation
Interventional model
Masking
31 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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