NCT02157051Active, not recruitingPhase 1
Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer
A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 3 Jun 2014
- Start date
- Jun 2015
- Primary completion date
- 25 Nov 2022
- Lead sponsor
- University of Washington
- Diseases
- Metastatic breast cancer
- NCT number
- NCT02157051
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 42
- From Jun 2015 to the primary completion date, 25 Nov 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 with any contraindication to receiving rhuGM-CSF based products
Other illness
- 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 clinically significant autoimmune disease uncontrolled with treatment
Other
- Patients who are simultaneously enrolled in any other treatment study
- Patients who are pregnant or breastfeeding
Who the study is looking for
- 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)
- Total bilirubin \<= 1.5 mg/dl (within 30 days of first vaccination)
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \<= 2 times upper limit of normal (ULN) (within 30 days of first vaccination)
- Blood glucose \< 1.5 ULN (within 30 days of first vaccination)
- All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.