New vaccine aims to train immune system against breast cancer stem cells
NCT ID NCT02157051
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a DNA vaccine called STEMVAC in 42 people with advanced HER2-negative breast cancer whose disease is stable or gone after standard treatment. The vaccine is designed to help the immune system recognize and attack cancer stem cells, which are often resistant to chemotherapy. The main goals are to check safety and see if the vaccine boosts the body's immune response against the cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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42 people
The number who actually took part.
- Started
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Jun 2015
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (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 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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