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Cancer Vaccine

Polysaccharide-K for HER2 Positive

Phase 1 & 2
Waitlist Available
Led By Lupe Salazar
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months after completion of treatment
Awards & highlights

Summary

This trial is testing a vaccine combined with standard breast cancer drugs. It targets patients with advanced HER2-positive breast cancer. The vaccine helps the immune system recognize and attack cancer cells, while the drugs block a protein that helps cancer grow. An additional substance might further boost the immune system’s ability to fight cancer.

Eligible Conditions
  • HER2 Positive
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months after completion of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months after completion of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With Grade 3 or Higher Toxicity Per Study Arm.
Secondary study objectives
Induction of Interferon (IFN)-Gamma Production and Cluster of Differentiation (CD)107a Expression in NK Cells, Via Flow Cytometry
Other study objectives
Change in Intermolecular Epitope Spreading Assessed by IFN-gamma Enzyme-linked Immunosorbent Spot Assay

Side effects data

From 2021 Phase 1 & 2 trial • 31 Patients • NCT01922921
87%
Injection site reaction
47%
Flu like symptoms
47%
Headache
40%
Anemia
40%
Diarrhea
27%
Lymphocyte count decreased
20%
White blood cell decreased
13%
Hypoalbuminemia
13%
Hyperglycemia
13%
Hypokalemia
13%
Cough
13%
Upper respiratory infection
13%
Fatigue
13%
Gastroesophageal reflux disease
7%
Rash maculo-papular
7%
Pain
7%
Blood bilirubin increase
7%
Post nasal drip
7%
Umbilical follicitis
7%
Scalp skin nodule
7%
Edema limbs
7%
Infusion related reactions
7%
Hypocalcemia
7%
Myalgia
7%
Right knee pain increased
7%
Left lip cold sores (Herpes)
7%
Paronychia
7%
Palpitations
7%
Cystitis - UTI
7%
Dyspnea
7%
Hot flashes
7%
Neutrophil count decreased
7%
Constipation
7%
Peripheral sensory neuropathy
7%
Hematochezia - 2 episodes
7%
Dyspepsia
7%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Placebo)
Arm II (Polysaccharide-K)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (polysaccharide-K)Experimental Treatment5 Interventions
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 II: Arm I (placebo)Active Control5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
HER-2/neu Intracellular Domain Protein
2014
Completed Phase 2
~40
Pertuzumab
FDA approved
Polysaccharide-K
2014
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Office of Cancer Complementary and Alternative MedicineUNKNOWN
University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,905,475 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,969 Total Patients Enrolled
~3 spots leftby Sep 2025
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