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HER2/Neu PositivePhase 1/2NCT01922921

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

A Phase 1/2 study testing HER-2/neu Intracellular Domain Protein, Laboratory Biomarker Analysis and Pertuzumab in people with HER2/Neu Positive and Recurrent Breast Carcinoma, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HER-2/neu Intracellular Domain Protein, Laboratory Biomarker Analysis and Pertuzumab
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteUnited States
Study dates
5 Feb 2014to 1 Sep 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase I/II Randomized Study of Combination Immunotherapy With or Without Polysaccharide Krestin (PSK®) Concurrently With a HER2 ICD Peptide-Based Vaccine in Patients With Stage IV Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety of polysaccharide-K (PSK) when given with HER2-directed immunotherapy.

SECONDARY OBJECTIVES:

  1. To evaluate the effect of PSK on natural killer (NK) cell functional activity when given with HER2-directed immunotherapy.

TERTIARY OBJECTIVES:

  1. 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.

Being tested
HER-2/neu Intracellular Domain Protein, Laboratory Biomarker Analysis, Pertuzumab, Placebo, Polysaccharide-K
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HER-2/neu Intracellular Domain ProteinBiological

    Also called HER-2 ICD Peptide, HER-2/neu ICD Protein, HER2 ICD, HER2 Intracellular Domain

    Given ID

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PertuzumabBiological

    Also called 2C4, 2C4 Antibody, MoAb 2C4, Monoclonal Antibody 2C4

    Given per standard of care

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given PO

  • Polysaccharide-KBiological

    Also called Glycoproteins, Krestin, KS-2, PSK

    Given PO

  • TrastuzumabBiological

    Also called ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2

    Given per standard of care

Study groups in NCT01922921
Study groupRoleWhat they receive
Arm I (placebo)Active comparatorPatients 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.
Receives: Biological: HER-2/neu Intracellular Domain Protein; Other: Laboratory Biomarker Analysis; Biological: Pertuzumab; Other: Placebo; Biological: Trastuzumab
Arm II (polysaccharide-K)ExperimentalPatients 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.
Receives: Biological: HER-2/neu Intracellular Domain Protein; Other: Laboratory Biomarker Analysis; Biological: Pertuzumab; Biological: Polysaccharide-K; Biological: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Grade 3 or Higher Toxicity Per Study Arm.

    Evaluated using physical examinations and clinical labs by type and grade of toxicities noted during treatment, There were graded per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events 4.0.

    Measured: Up to 4 months

Secondary outcomes (1)

  1. Induction of Interferon (IFN)-Gamma Production and Cluster of Differentiation (CD)107a Expression in NK Cells, Via Flow Cytometry

    Augmentation of NK cell activity is defined by a 2-fold increase (at time of maximal change) in NK cell IFN-gamma production and CD107a expression

    For the results we used CD56 which is the accepted phenotypic marker for natural killer (NK) cells and CD16 which is a receptor on NK cells that facilitates antibody-dependent cellular cytotoxicity (ADCC). CD56dim are typically responsible for cytolytic activity and targets cell killing, whereas, CD56bright are the main source of cytokine production (i.e. IFN-gamma). CD56dim CD16bright NK cells represent at least 90% of all peripheral blood NK cells with a maximum of 10% as CD56bright NK cells

    We compared the baseline expression of CD56brightCD16dim or CD56dimCD16bright (prior to start of study treatment) to the maximum expression of CD56brightCD16dim or CD56dimCD16bright at 1 of 4 timepoints after the start of the oral administration of study treatment (polysaccharide-K/placebo (either week 4, 8, 12 or 16).

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2013 (estimated)
  2. Study start5 Feb 2014
  3. Primary completion31 Oct 2019
  4. Study completion1 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01922921
Sponsor's protocol ID
7866
Other IDs
NCI-2013-01377, 135, 7866/135, 7866, P30CA015704, U19AT006028
Status last verified
Apr 2023
First submitted
1 Aug 2013
Last updated
18 Apr 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HER-2/neu Intracellular Domain Protein, Laboratory Biomarker Analysis and Pertuzumab in people with HER2/Neu Positive and Recurrent Breast Carcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Grade 3 or Higher Toxicity Per Study Arm. (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01922921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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