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NCT05455658Active, not recruitingPhase 2

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

A Phase II Trial of The Immunogenicity of a DNA Plasmid Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDC25B, CD105) in Participants With Early Stage Triple Negative Breast Cancer

Source: ClinicalTrials.gov · Last updated 23 Jul 2026

Brief summary (registry, in English)

This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC targets proteins that are expressed on breast cancer cells and works by boosting the immune system to recognize and destroy the invader cancer cell proteins that are causing the disease. The purpose of this trial is to test the immune system's response to STEMVAC.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
33 (actual)
First submitted
30 Jun 2022
Start date
17 Nov 2022
Primary completion date
1 Jun 2026
Lead sponsor
University of Washington
NCT number
NCT05455658

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 33
  • From 17 Nov 2022 to the primary completion date, 1 Jun 2026
  • 3 sites 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

  • Contraindication or known hypersensitivity to receiving sargramostim (rhuGM-CSF) or other products
  • 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

Other illness

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to STEMVAC
  • 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
  • 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
  • History of invasive breast cancer prior to TNBC diagnosis \* Note: Prior DCIS is allowable

Other

  • Pregnant and breastfeeding women are excluded from this study
  • Chronic usage of immunosuppressants and glucocorticoids (methotrexate for RA, etc.)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
Fred Hutch/University of Washington Cancer Consortium
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.