Could a vaccine keep triple negative breast cancer from returning?
NCT ID NCT05455658
First seen Jun 24, 2026 · Last updated Jul 24, 2026 · Updated 3 times
Summary
This phase II trial tests a DNA-based vaccine called STEMVAC in 33 people with early-stage triple negative breast cancer (stages IB-III). The vaccine is designed to train the immune system to recognize and attack cancer cells that express certain proteins. Participants also receive an immune booster (sargramostim). The main goal is to see if the vaccine triggers a strong immune response, not yet to measure cancer recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STEMVAC (a DNA plasmid vaccine) and sargramostim (an immune booster)
- What this could lead to
- If successful, this could lead to a vaccine that helps prevent triple negative breast cancer from coming back after initial treatment.
- What could go wrong
- This is a small, early-phase trial (33 people) focused on immune response, not yet on preventing recurrence. The vaccine may not produce a strong enough immune reaction or may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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33 people
The number who actually took part.
- Started
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Nov 2022
- Expected to finish
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Jul 2028
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: * Participants with triple negative breast cancer, stages IB, II or III. Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative is defined as breast cancer with less than 10% of ER or PR expression. HER2 negative is defined as: * 0-1+ HER2 expression by immunohistochemistry (IHC) OR * Fluorescence in situ hybridization (FISH) negative OR * HER2 2+ and FISH negative * Note: Participants with low ER positivity (≤10%) who are already on adjuvant hormonal therapy will be allowed on study and can continue their adjuvant hormonal treatment during study participation. * Participants must have completed all standard of care (or investigational) systemic therapy (including immune modulating agents) and radiotherapy if used between 28 and 365 days prior to enrollment \* Note: Treatment with a bisphosphonate or denosumab to prevent bone loss is not considered to be systemic therapy for breast cancer and its use within the 28 day pre-enrollment period or while on study is not exclusionary. Treatment with adjuvant olaparib within the 28 day pre-enrollment period or while on study is not exclusionary. * Participants must agree to avoid systemic steroids for the duration of the treatment period and until completion of the 1 month post 2nd booster vaccine visit (end of treatment) * Participants must be at least 18 years of age \* Note: Because no dosing or adverse event (AE) data are currently available on the use of STEMVAC in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable. * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 * White blood cell (WBC) \>= 3000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Lymphocyte count \>= 800/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Platelet count \>= 100,000/mm\^3 (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Hemoglobin (Hgb) \>= 10 g/dl (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Serum creatinine =\< 1.2 mg/dl OR creatinine clearance \> 60 ml/min (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * Total bilirubin =\< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * AST (aspartate aminotransferase)/serum glutamic-oxaloacetic transaminase (SGOT) =\< 1.5 X upper limit of institutional normal (ULN) (within 60 days of enrollment and at least 28 days post standard of care \[SOC\] treatment) * 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 or condition precluding protocol treatment * The effects of STEMVAC on the developing human fetus are unknown. For this reason, * Female participant agrees to use adequate contraception (examples include: estrogen and/or progestogen containing hormonal contraception, barrier method (condom, cervical cap) or abstinence) while on the study and until 1 month after the 2nd booster vaccination when/if engaging in sex that could lead to pregnancy. Exceptions: Females who have had a hysterectomy, tubal ligation or bilateral oophorectomy OR meet one of the following criteria for postmenopausal: Age \> 60 or age \< 60 with \>= 12 months amenorrhea and follicle-stimulating hormone (FSH) within the testing facility's postmenopausal range * Female participant agrees to inform her study physician immediately should she become pregnant or suspect she is pregnant while participating in this study * Male participants who are having sex that can lead to pregnancy must use an acceptable form of contraception (vasectomy with the absence of sperm, sexual abstinence, condoms) throughout the course of the study * Must be 14 days between a vaccine (i.e. COVID19, Flu, shingrix, Tdap, etc.) and any STEMVAC vaccination. \*\*Note: This does not apply to the Td vaccine. * Patients must be willing to not undergo major elective surgical procedures with general anesthesia or conscious sedation through the end of treatment visit. (Note: port removal is allowable) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Contraindication or known hypersensitivity to receiving sargramostim (rhuGM-CSF) or other products * History of allergic reactions attributed to compounds of similar chemical or biologic composition to STEMVAC * Participants receiving any other investigational agents * Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) is prohibited during the treatment period of the study, except when taken as low-dose (81 mg) aspirin therapy. Prohibited chronic use is defined as daily use for more than 7 days * Participants with any clinically significant autoimmune disease uncontrolled with treatment * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and breastfeeding women are excluded from this study * Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C \* Note: These individuals are excluded in order to avoid confounding an existing condition with an immune response to STEMVAC * Chronic usage of immunosuppressants and glucocorticoids (methotrexate for RA, etc.) * History of invasive breast cancer prior to TNBC diagnosis \* Note: Prior DCIS is allowable
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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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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
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University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
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