Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-05

Study Completion Date

2021-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HER2/Neu Positive Recurrent Breast Carcinoma Stage IV Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (placebo)

Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab (or trastuzumab and pertuzumab) per standard of care, and placebo PO BID for 4 months.

Group Type ACTIVE_COMPARATOR

HER-2/neu Intracellular Domain Protein

Intervention Type BIOLOGICAL

Given ID

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Pertuzumab

Intervention Type BIOLOGICAL

Given per standard of care

Placebo

Intervention Type OTHER

Given PO

Trastuzumab

Intervention Type BIOLOGICAL

Given per standard of care

Arm II (polysaccharide-K)

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.

Group Type EXPERIMENTAL

HER-2/neu Intracellular Domain Protein

Intervention Type BIOLOGICAL

Given ID

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Pertuzumab

Intervention Type BIOLOGICAL

Given per standard of care

Polysaccharide-K

Intervention Type BIOLOGICAL

Given PO

Trastuzumab

Intervention Type BIOLOGICAL

Given per standard of care

Interventions

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HER-2/neu Intracellular Domain Protein

Given ID

Intervention Type BIOLOGICAL

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Pertuzumab

Given per standard of care

Intervention Type BIOLOGICAL

Placebo

Given PO

Intervention Type OTHER

Polysaccharide-K

Given PO

Intervention Type BIOLOGICAL

Trastuzumab

Given per standard of care

Intervention Type BIOLOGICAL

Other Intervention Names

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HER-2 ICD Peptide HER-2/neu ICD Protein HER2 ICD HER2 Intracellular Domain 2C4 2C4 Antibody MoAb 2C4 Monoclonal Antibody 2C4 Perjeta rhuMAb2C4 RO4368451 placebo therapy PLCB sham therapy Glycoproteins Krestin KS-2 PSK ABP 980 Anti-c-ERB-2 Anti-c-erbB2 Monoclonal Antibody Anti-ERB-2 Anti-erbB-2 Anti-erbB2 Monoclonal Antibody Anti-HER2/c-erbB2 Monoclonal Antibody Anti-p185-HER2 c-erb-2 Monoclonal Antibody HER2 Monoclonal Antibody Herceptin Herceptin Biosimilar PF-05280014 Herceptin Trastuzumab Biosimilar PF-05280014 MoAb HER2 Monoclonal Antibody c-erb-2 Monoclonal Antibody HER2 PF-05280014 rhuMAb HER2 RO0452317 Trastuzumab Biosimilar ABP 980 Trastuzumab Biosimilar PF-05280014

Eligibility Criteria

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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 =\< 2+ must have HER2 gene amplification documented by FISH
* 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
* Patients must be at least 21 days post cytotoxic chemotherapy prior to enrollment
* Patients must be at least 28 days post immunosuppressants prior to enrollment
* 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)
* Patients on bisphosphonates and/or endocrine therapy are eligible
* Patients who are having sex that could lead to pregnancy must agree to contraceptive use during the entire study period
* Patients must have Zubrod performance status score of =\< 2
* 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
* White blood cell (WBC) \>= 3000/mm\^3
* Hemoglobin (Hgb) \>= 10 g/dl
* Serum creatinine =\< 2.0 mg/dl or creatinine clearance \> 60 ml/min
* Total bilirubin =\< 1.5 mg/dl
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 times the upper limit of normal
* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No