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STEMVAC Vaccine for Triple-Negative Breast Cancer

This study is testing a vaccine called STEMVAC (CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine) along with a drug called recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) to see if it can help people with triple-negative breast cancer (TNBC) live longer without their cancer coming back. This is for patients who still have some cancer left after their initial chemotherapy and surgery. The study aims to enroll 60 participants aged 18 or older who have TNBC and a good performance status. Researchers will measure how long patients live without their cancer returning (invasive breast cancer free survival) for up to 3 years, and also look at changes in circulating tumor DNA (ctDNA) after vaccination. The study is currently recruiting.

Study design
This is an interventional study that plans to enroll 60 participants. Participants will be randomly assigned to one of two groups.
What's involved
You would receive injections of the vaccine and/or GM-CSF every 3 weeks for 3 doses, followed by two booster injections. You would also have blood samples collected throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up at 3 weeks after your last vaccination and then every 6 months for 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07721259

A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~60 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineRecombinant Granulocyte-Macrophage Colony-Stimulating FactorBiospecimen Collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Invasive breast cancer free survival (IBCFS)
Measured over Time from randomization to local or distant recurrence or death, assessed up to 3 years
+1 more outcome measured

Conditions

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Triple-Negative Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Natasha Hunter, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Research Coordinator(s)
[email protected]
866-932-8588
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

At least 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2
Triple-negative breast cancer as determined by the treating oncologist
Completed standard of care neoadjuvant chemotherapy in the opinion of their treating oncologist
Patients whose tumors progress on neoadjuvant therapy may be enrolled
No clinical evidence of local or distant recurrence
Plan to receive standard of care adjuvant directed therapy
Completed standard of care locoregional treatment, including definitive breast and lymph node surgery followed by standard radiation therapy, if recommended
Residual cancer burden (RCB) index 2 or 3 as calculated per routine anatomic pathology clinical standards
Absolute neutrophil count (ANC) ≥ 800/μL (within 30 days of first study vaccine administration)
Hemoglobin (Hgb) ≥ 8 g/dL (within 30 days of first study vaccine administration)
Platelets ≥ 75,000/ μL (within 30 days of first study vaccine administration)
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome, in whom total bilirubin must be \< 3.0 mg/dL (within 30 days of first study vaccine administration)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (within 30 days of first study vaccine administration)
Creatinine ≤ 1.5 x ULN mg/dL or creatinine clearance \> 60 mL/min (within 30 days of first study vaccine administration)
At least 28 days post systemic steroids prior to enrollment, unless used as part of prophylaxis to prevent intravenous (IV) contrast reactions.
Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed
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
Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a person of child-bearing potential. Acceptable methods of contraception are abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal

Exclusion

Toxicities related to prior exposure to immune checkpoint inhibitors for which immune checkpoint inhibitors cannot be safely continued as determined by study investigator
Germline BRCA1 or BRCA2 mutations with adjuvant olaparib planned within the study period
NOTE: If olaparib is not planned, then these patients are eligible
Any known cardiac conditions:
Symptomatic restrictive cardiomyopathy
Dilated 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
Autoimmune disease requiring active systemic treatment
Known hypersensitivity reaction to the GM-CSF adjuvant; any known contra-indication to GM-CSF
Pregnant or breast feeding
Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive), or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] is detected)
Major surgery within the 4 weeks prior to initiation of first study vaccine
Enrollment in any other clinical protocol or investigational trial that involves concurrent administration of experimental therapy and/or therapeutic devices, or investigational drug. Patients who completed prior clinical trials (such as neoadjuvant treatment, surgery or radiation trials) and are on long term follow up are permitted

What this trial measures

  • Invasive breast cancer free survival (IBCFS)Time from randomization to local or distant recurrence or death, assessed up to 3 years

    Kaplan-Meier curves will be generated with median estimation and 95% confidence interval, and log-rank tests will be conducted to compare the survival difference between groups. Will calculate the 3-year IBCFS rate with a 95% confidence interval from Kaplan-Meier methods using Greenwood standard errors.

  • Dynamics and characteristics of circulating tumor deoxyribonucleic acid (ctDNA)Up to 3 weeks after last vaccination

    Through serial ctDNA evaluation, each sample will be assessed for ctDNA detectability and, if detectable, total ctDNA mass (continuous variable, as reported by the assay platform) will be calculated. ctDNA detectability and quantitative ctDNA measures will be summarized descriptively by timepoint and study arm, and changes over time will be evaluated using methods appropriate to the final endpoint definition, data distribution, and repeated-measures structure of the data. Associations with IBCFS will also be explored. Copy number variants (including aneuploidy, chromosome-level gains, losses, and amplifications, as defined by the final assay methodology) will also be tracked and tabulated, and changes over time will be evaluated descriptively in both study arms.