Trial · NCT05455658
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
NCT05455658, Phase 2, Active not recruiting, University of Washington
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. STEMVAC in Patients With Early Stage Triple Negative Breast Cancer. Trials, record NCT05455658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05455658
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
- NCT number
- NCT05455658
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
- Interventions
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Sargramostim
- First posted
- 2022-07-13
- Last updated
- 2026-07-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cellular immune response: incidence | At 1 month after 3rd vaccination | Defined by the incidence of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). |
| Primary | Cellular immune response: incidence | At 10 months after 3rd vaccination | Defined by the incidence of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). |
| Primary | Cellular immune response: magnitude | At 1 month after 3rd vaccination | Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point. |
| Primary | Cellular immune response: magnitude | At 3 months after 3rd vaccination | Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point. |
| Primary | Cellular immune response: magnitude | At 9 months after 3rd vaccination | Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point. |
| Primary | Cellular immune response: magnitude | At 10 months after 3rd vaccination | Defined by the magnitude of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT). The magnitude of immune response is defined as the sum of the corrected spots/well values calculated at each time point. |
| Secondary | Kinetics of the magnitude of antigen specific IFN-gamma ELISPOT counts | 13 months | Will be assessed over time from pre to post immunization to determine if pre-existent immunity affects magnitude of response. |
| Secondary | Incidence of adverse events | 1 month after last booster vaccine | Safety and systemic toxicity will be determined by chemical and clinical parameters evaluated at various time points. Toxicity grading will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events will be done per Food and Drug Administration and NCI guidelines. |
| Secondary | Activation status and repertoire diversity of peripheral blood T-cells | Prior to and after STEMVAC vaccination | The peripheral T cell repertoire diversity will be determined by high-throughput deoxyribonucleic acid (DNA) sequencing of the recombined V(D)J region of the T cell receptor beta-chain (TCRB) using the immunoSEQ platform (Adaptive Biotechnologies) on antigen-specific T-cells from a short-term in vitro culture. The activation, exhaustion and memory status of the peripheral T cells will be determined by flow cytometry using fluorochrome linked antibodies to PD-1, CD4, CD3, LAG3, CD137, CD8, KLGR1, CD44, CD69, CD62L and OX40. Transcription factors for Th1 (Tbet), Th2 (GATA3) and Treg (FOXP3) will also be evaluated. All results will be summarized using simple descriptive statistics. |
| Secondary | Relapse free survival (RFS) | Up to 5 years | Will explore if adjuvant vaccination with STEMVAC improves relapse free survival as compared to historical controls. Local and distant recurrence at year 5 will be reported as proportion with confidence intervals, and RFS will be estimated using Kaplan-Meier method with the 5-year RFS rate estimated from the Kaplan-Meier estimate of the survival distribution along with a 95% confidence interval. Comparison of the local and distant recurrence and 5-year RFS against the historical control will be based on a binomial test. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG1CA242635 | The MW Cancer Prevention Clinical Trials Network | BARROILHET, LISA M | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL CANCER INSTITUTE | 2020 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05455658
GET https://conductscience.org/api/trials/v1/NCT05455658/registered