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Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer

NCT02157051 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-02-17

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based vaccine may target immunogenic proteins expressed in breast cancer stem cells which are the component of breast cancer that is resistant to chemotherapy and has the ability to spread. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells.

Conditions

  • HER2 Negative Breast Carcinoma
  • Recurrent Breast Carcinoma
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage III Breast Cancer

Interventions

BIOLOGICAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Given ID

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Breast Cancer Alliance

    collaborator OTHER

  • University of Washington

    lead OTHER

Principal Investigators

  • Mary Disis · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2022-11-25
Completion
2026-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02157051 on ClinicalTrials.gov