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

NCT01922921 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-04-18

Study results available
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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. 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.

Conditions

  • HER2/Neu Positive
  • Recurrent Breast Carcinoma
  • Stage IV Breast Cancer

Interventions

BIOLOGICAL

HER-2/neu Intracellular Domain Protein

Given ID

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pertuzumab

Given per standard of care

OTHER

Placebo

Given PO

BIOLOGICAL

Polysaccharide-K

Given PO

BIOLOGICAL

Trastuzumab

Given per standard of care

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Lupe Salazar · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-05
Primary Completion
2019-10-31
Completion
2021-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922921 on ClinicalTrials.gov