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

NCT02157051 | Active Not Recruiting Phase 1

• 4 other identifiers: 9140NCI-2014-01070137RG1715017
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence of toxicity per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 4.0

  The type and grade of toxicities noted during the immunization regimen will be summarized. Adverse events noted by the investigator/designated clinical research staff will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical and/or laboratory parameters.

  Up to 1 month after last vaccine

• Immunologic efficacy defined as achievement of a statistically significant increase in Th1 cell immunity for at least 50% of the immunizing antigens as compared to baseline

  Up to 5 years

Secondary Outcomes (5)

• Memory Th1 dominant immune response to all five antigens over time

  Up to 12 months

• Modulation of T-regulatory (Treg) cells with vaccination

  Up to 12 months

• Modulation of MDSC with vaccination

  Up to 12 months

• STEMVAC specific Type 1 immune response

  Up to 12 months

• Bac-TA cross-reactive T-cells

  Up to 12 months

Study Arms (4)

Arm 1 (STEMVAC)

EXPERIMENTAL

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 1 injection ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Other: Laboratory Biomarker Analysis

Arm 2 (STEMVAC)

EXPERIMENTAL

Patients receive CD105/Yb-1/SOX2/CDH3/M2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Other: Laboratory Biomarker Analysis

Arm 3 (STEMVAC)

EXPERIMENTAL

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 3 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Other: Laboratory Biomarker Analysis

Arm 4 (STEMVAC)

EXPERIMENTAL

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 1 additional STEMVAC vaccine at 3 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Other: Laboratory Biomarker Analysis

Interventions

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

Given ID

Also known as: CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC, STEMVAC Th1 Polyepitope Plasmid-based Vaccine

Arm 1 (STEMVAC); Arm 2 (STEMVAC); Arm 3 (STEMVAC); Arm 4 (STEMVAC)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm 1 (STEMVAC); Arm 2 (STEMVAC); Arm 3 (STEMVAC); Arm 4 (STEMVAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have:
• No evidence of disease (NED), or
• Stable bone only disease
• Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy
• Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollment
• Patients must be at least 28 days post systemic steroids prior to enrollment
• Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 1
• Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
• Estimated life expectancy of more than 6 months
• White blood cells (WBC) \>= 3000/mm\^3 (within 30 days of first vaccination)
• Lymphocyte count \>= 800/mm\^3 (within 30 days of first vaccination)
• Platelet count \>= 75,000/mm\^3 (within 30 days of first vaccination)
• Hemoglobin (Hgb) \>= 10 g/dl (within 30 days of first vaccination)
• Serum creatinine \<= 1.2 mg/dl or creatinine clearance \> 60 ml/min (within 30 days of first vaccination)

You may not qualify if:

• Patients with any of the following cardiac conditions:
• Symptomatic restrictive cardiomyopathy
• Unstable angina within 4 months prior to enrollment
• New York Heart Association functional class III-IV heart failure on active treatment
• Symptomatic pericardial effusion
• Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use)
• Patients with any seizure disorder
• Patients with any contraindication to receiving rhuGM-CSF based products
• Patients with any clinically significant autoimmune disease uncontrolled with treatment
• Patients who are simultaneously enrolled in any other treatment study
• Patients who are pregnant or breastfeeding

Sponsors & Collaborators

• University of Washington: lead
• United States Department of Defense: collaborator
• Breast Cancer Alliance: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mary Disis

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: June 1, 2015
• Primary Completion: November 25, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)