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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of Washington
Information provided by (Responsible Party):
University of Washington Identifier:
First received: June 3, 2014
Last updated: June 5, 2015
Last verified: June 2015

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.

Condition Intervention Phase
HER2-negative Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Biological: CD105/Yb-1/SOX2/CDH3/MDM2 multiplasmid vaccine
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Incidence of toxicity per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Memory Th1 dominant immune response to all five antigens over time [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Modulation of T-regulatory (Treg) cells with vaccination [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Treg defined as present or absent, and the probability will be estimated as a simple proportion.

  • Modulation of MDSC with vaccination [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    MDSC defined as present or absent, and the probability will be estimated as a simple proportion.

Estimated Enrollment: 30
Study Start Date: June 2015
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (STEMVAC)
Patients receive CD105/Yb-1/SOX2/CDH3/MDM2 multiplasmid vaccine with rhuGM-CSF ID every 28 days for 3 months and booster vaccines at 6 and 12 months in the absence of disease progression or unacceptable toxicity.
Biological: CD105/Yb-1/SOX2/CDH3/MDM2 multiplasmid vaccine
Given ID
Other Name: STEMVAC Th1 polyepitope plasmid-based vaccine
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


I. To determine the safety of intradermal administration of up to 3 escalating doses of CD105/Yb-1/SOX2 CDH3/MDM2 multiplasmid vaccine (STEMVAC) in patients with HER2-negative advanced stage breast cancer.

II. To determine the most immunogenic dose of STEMVAC in patients with HER2-negative advanced stage breast cancer.


I. To determine whether a STEMVAC T helper 1 cells (Th1) polyepitope plasmid based vaccine elicits a persistent memory T cell response and whether immunity can be further enhanced/maintained by two additional STEMVAC vaccines (boosters) given 3 and 9 months after the priming regimen.

II. To evaluate whether STEMVAC vaccination modulates T regulatory cells and myeloid-derived suppressor cells (MDSC).

OUTLINE: This is a dose-escalation study.

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2 multiplasmid vaccine with rhuGM-CSF intradermally (ID) every 28 days for 3 months and booster vaccines at 6 and 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up twice yearly for 5 years.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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, prior to enrollment
  • Patients must be at least 28 days post systemic steroids prior to enrollment
  • Patients on bisphosphonates 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
  • Hemoglobin (Hgb) >= 10 mg/dl
  • Serum creatinine =< 1.2 mg/dl when adjusted for body surface area (BSA) or creatinine clearance > 60 ml/min
  • Total bilirubin =< 1.5 mg/dl
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 2 times upper limit of normal (ULN)
  • Blood glucose < 1.5 ULN
  • Postmenopausal women determined by one of the following:

    • Bilateral surgical oophorectomy
    • Age greater than or equal 60 years
    • Age < 60 years, with amenorrhea greater than or equal to 12 months and follicle-stimulating hormone within postmenopausal range
  • Non-menopausal female patients must agree to contraception for the remainder of their childbearing years
  • Male patients must use an acceptable form of contraception throughout the course of the study

Exclusion Criteria:

  • 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 contraindication to receiving recombinant human granulocyte-macrophage colony stimulating factor; GM-CSF; LEUKINE® (sargramostim) (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02157051

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Mary L. Disis    206-616-1823      
Principal Investigator: Mary L. Disis         
Sponsors and Collaborators
University of Washington
Principal Investigator: Mary Disis Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington Identifier: NCT02157051     History of Changes
Other Study ID Numbers: 9140, NCI-2014-01070, 137, 9140, P30CA015704
Study First Received: June 3, 2014
Last Updated: June 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on July 05, 2015