Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT07721259
A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden
A Phase 2 study testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Recombinant Granulocyte-Macrophage Colony-Stimulating Factor and Biospecimen Collection in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial evaluates whether a multi-antigen vaccine called STEMVAC improves disease-free survival after surgery in patients with triple-negative breast cancer (TNBC) and moderate or extensive residual cancer burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Recombinant Granulocyte-Macrophage Colony-Stimulating Factor and Biospecimen Collection
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 16 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Research Coordinator(s), 866-932-8588, cvitrial@uw.edu
Natasha Hunter, MD
About this study
Official title: A Multiantigen Vaccine (STEMVAC) for Adjuvant Treatment of Patients With Moderate or Extensive Residual Triple-Negative Breast Cancer
This phase II trial evaluates whether a multi-antigen vaccine called STEMVAC improves disease-free survival after surgery in patients with triple-negative breast cancer (TNBC) and moderate or extensive residual cancer burden. TNBC has an aggressive clinical course and poorer disease-free survival compared to other subtypes. While patients who have no remaining tumor in the breast or lymph nodes after surgery have excellent long-term outcomes, patients with moderate or extensive residual cancer burden remain at high risk for early disease return and poorer prognosis. STEMVAC is designed to target proteins that tumor cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Giving STEMVAC after surgery may improve disease-free survival rates in TNBC patients with moderate or extensive residual cancer burden.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid deoxyribonucleic acid (DNA) vaccine (STEMVAC) with recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) intradermally (ID) every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial.
ARM B: Patients receive GM-CSF ID every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 3 weeks after their last vaccination and then every 6 months for 3 years.
- 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
- Being tested
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Recombinant Granulocyte-Macrophage Colony-Stimulating Factor, Biospecimen Collection
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineBiological
Also called CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC, STEMVAC Th1 Polyepitope Plasmid-based Vaccine
Given ID
Recombinant Granulocyte-Macrophage Colony-Stimulating FactorDrug
Also called Colony-Stimulating Factor, Granulocyte-Macrophage, CSF 39300, CSF 39300/GM-CSF, CSF-GM (Hoechst)
Given ID
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
| Study group | Role | What they receive |
|---|---|---|
| Arm A (STEMVAC, GM-CSF) | Experimental | Patients receive STEMVAC with GM-CSF ID every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial. Receives: Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; Drug: Recombinant Granulocyte-Macrophage Colony-Stimulating Factor; Procedure: Biospecimen Collection |
| Arm B (GM-CSF) | Active comparator | Patients receive GM-CSF ID every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial. Receives: Drug: Recombinant Granulocyte-Macrophage Colony-Stimulating Factor; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive breast cancer free survival (IBCFS)
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.
Measured: Time from randomization to local or distant recurrence or death, assessed up to 3 years
Dynamics and characteristics of circulating tumor deoxyribonucleic acid (ctDNA)
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.
Measured: Up to 3 weeks after last vaccination
Secondary outcomes (3)
Incidence of adverse events
Safety and systemic toxicity will be determined by clinical and laboratory parameters evaluated at protocol-specified time points. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0. The type and grade of toxicities observed during the immunization regimen will be summarized, and the duration of toxicities will be summarized using descriptive statistics. All adverse events reported by the investigator will be tabulated according to the affected body system. The frequency and severity of adverse events will be summarized using proportions and corresponding 95% confidence intervals. Demographic and baseline characteristics obtained at enrollment will be summarized in tabular and/or graphical formats using descriptive statistics.
Measured: Up to 3 weeks after last vaccination
Immune response
Immune response to CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine (STEMVAC) will be measured in peripheral blood functionally by IFN-g enzyme-linked immunosorbent spot, phenotypically using cytometry by time-of-flight to identify T-cell clonal populations, and genomically, using T-cell receptor beta sequencing of CD4+ CD8+ T-cells.
Measured: Up to 3 weeks after last vaccination
Expression of epithelial to mesenchymal transformation (EMT)-associated genes
EMT-associated gene expression profiles in residual triple negative breast cancer in surgical pathology samples will be defined for each patient with particular attention on STEMVAC antigen expression. Expression of these EMT-related genes will be assessed using RNA extracted from formalin-fixed paraffin-embedded tissue.
Measured: Archival tissue is collected after enrollment, within 30 days of baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion16 Jul 2029 (estimated)
- Study completion16 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Natasha Hunter, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721259
- Sponsor's protocol ID
- RG1126489
- Other IDs
- NCI-2026-04722, FHIRB0021357
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiantigen Vaccine (STEMVAC) for Adjuvant Treatment of Patients With Moderate or Extensive Residual Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07721259
- Acronym / sponsor ID
- RG1126489
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 16 Jul 2029 (estimated)
- Study completion
- 16 Jul 2030 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial evaluates whether a multi-antigen vaccine called STEMVAC improves disease-free survival after surgery in patients with triple-negative breast cancer (TNBC) and moderate or extensive residual cancer burden. TNBC has an aggressive clinical course and poorer disease-free survival compared to other subtypes. While patients who have no remaining tumor in the breast or lymph nodes after surgery have excellent long-term outcomes, patients with moderate or extensive residual cancer burden remain at high risk for early disease return and poorer prognosis. STEMVAC is designed to target proteins that tumor cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Giving STEMVAC after surgery may improve disease-free survival rates in TNBC patients with moderate or extensive residual cancer burden.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid deoxyribonucleic acid (DNA) vaccine (STEMVAC) with recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) intradermally (ID) every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial.
ARM B: Patients receive GM-CSF ID every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up at 3 weeks after their last vaccination and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (STEMVAC, GM-CSF) | Experimental | Biological: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Drug: Recombinant Granulocyte-Macrophage Colony-Stimulating Factor, Procedure: Biospecimen CollectionPatients receive STEMVAC with GM-CSF ID every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial. |
| Arm B (GM-CSF) | Active comparator | Drug: Recombinant Granulocyte-Macrophage Colony-Stimulating Factor, Procedure: Biospecimen CollectionPatients receive GM-CSF ID every 3 weeks for 3 doses. Patients then receive booster vaccines ID 9 weeks after vaccine 3 and 18 weeks after booster 1. Patients also undergo collection of blood samples throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (15 listed)
- 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
- Any known cardiac conditions:
- Autoimmune disease requiring active systemic treatment
- Known hypersensitivity reaction to the GM-CSF adjuvant; any known contra-indication to GM-CSF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineAlso: CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine, STEMVAC, STEMVAC Th1 Polyepitope Plasmid-based VaccineGiven ID | Biological | Arm A (STEMVAC, GM-CSF) |
| Recombinant Granulocyte-Macrophage Colony-Stimulating FactorAlso: Colony-Stimulating Factor, Granulocyte-Macrophage, CSF 39300, CSF 39300/GM-CSF, CSF-GM (Hoechst)Given ID | Drug | Arm A (STEMVAC, GM-CSF), Arm B (GM-CSF) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Arm A (STEMVAC, GM-CSF), Arm B (GM-CSF) |
Primary outcome
Invasive breast cancer free survival (IBCFS)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Incidence of adverse events
Time frame: Up to 3 weeks after last vaccination
Immune response
Time frame: Up to 3 weeks after last vaccination
Expression of epithelial to mesenchymal transformation (EMT)-associated genes
Time frame: Archival tissue is collected after enrollment, within 30 days of baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natasha Hunter, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Recombinant Granulocyte-Macrophage Colony-Stimulating Factor and Biospecimen Collection in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator(s) (866-932-8588, cvitrial@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive breast cancer free survival (IBCFS) (time frame: Time from randomization to local or distant recurrence or death, assessed up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.