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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

All Individual Drugs Already Approved

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

Breast cancer
HER2 Positive
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months after completion of treatment

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

Rash maculo-papular

Pain

Blood bilirubin increase

Post nasal drip

Umbilical follicitis

Scalp skin nodule

Edema limbs

Infusion related reactions

Hypocalcemia

Myalgia

Right knee pain increased

Left lip cold sores (Herpes)

Paronychia

Palpitations

Cystitis - UTI

Dyspnea

Hot flashes

Neutrophil count decreased

Constipation

Peripheral sensory neuropathy

Hematochezia - 2 episodes

Dyspepsia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Placebo)

Arm II (Polysaccharide-K)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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