Last reviewed · How we verify
NCT05455658
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
Phase 2 trial testing CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine in Anatomic Stage IB Breast Cancer AJCC v8 in 33 participants. Participants enrolled and being followed up; not accepting new ones.
16 July 2026
Quick facts
| Lead sponsor | University of Washington |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 33 |
| Start date | 17 November 2022 |
| Primary completion | 16 July 2026 |
| Estimated completion | 16 July 2028 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine — full drug profile →
- Sargramostim (SARGRAMOSTIM) — full drug profile →
Conditions studied
- Anatomic Stage IB Breast Cancer AJCC v8 — all drugs for Anatomic Stage IB Breast Cancer AJCC v8 →
- Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →
- Anatomic Stage IIA Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIA Breast Cancer AJCC v8 →
- Anatomic Stage IIB Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIB Breast Cancer AJCC v8 →
Sponsor
University of Washington
Who can join
18 and older, any sex, with Anatomic Stage IB Breast Cancer AJCC v8 or Anatomic Stage II Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic cancer vaccines: advancements, challenges, and prospects.
Fan T, Zhang M, Yang J, Zhu Z, et al · · 2023 · cited 314× · PMID 38086815 · DOI 10.1038/s41392-023-01674-3 -
The next-generation DNA vaccine platforms and delivery systems: advances, challenges and prospects.
Lu B, Lim JM, Yu B, Song S, et al · · 2024 · cited 84× · PMID 38361919 · DOI 10.3389/fimmu.2024.1332939 -
The future of cancer immunotherapy: DNA vaccines leading the way.
Pandya A, Shah Y, Kothari N, Postwala H, et al · · 2023 · cited 53× · PMID 37294501 · DOI 10.1007/s12032-023-02060-3 -
Current and future immunotherapy for breast cancer.
Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z -
Cancer stem cells: landscape, challenges and emerging therapeutic innovations.
Lee H, Kim B, Park J, Park S, et al · · 2025 · cited 37× · PMID 40759634 · DOI 10.1038/s41392-025-02360-2 -
Y-Box Binding Protein 1: Unraveling the Multifaceted Role in Cancer Development and Therapeutic Potential.
Dinh NTM, Nguyen TM, Park MK, Lee CH. · · 2024 · cited 37× · PMID 38255791 · DOI 10.3390/ijms25020717 -
Current Landscape of Cancer Immunotherapy: Harnessing the Immune Arsenal to Overcome Immune Evasion.
Mitra A, Kumar A, Amdare NP, Pathak R. · · 2024 · cited 34× · PMID 38785789 · DOI 10.3390/biology13050307 -
Advances in nucleic acid-based cancer vaccines.
Liao HC, Liu SJ. · · 2025 · cited 25× · PMID 39833784 · DOI 10.1186/s12929-024-01102-w
Verify or expand the search:
- PubMed search for NCT05455658
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
Trials testing the same drug.
- NCT07078604 — A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negati · Phase 2 · recruiting
- NCT07112053 — A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Recept · Phase 2 · recruiting
- NCT05242965 — A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer · Phase 2 · active not recruiting
Other recruiting trials for Anatomic Stage IB Breast Cancer AJCC v8
Currently open trials in the same condition.
- NCT06324240 — Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Canc · Phase 1 · recruiting
- NCT05417308 — Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Can · EARLY_PHASE1 · recruiting
- NCT05368428 — Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III E · NA · recruiting
- NCT05243056 — A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment · NA · recruiting
- NCT05452681 — Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors · NA · recruiting
Other University of Washington trials
Trials by the same sponsor.
- NCT07430852 — Inherited and Environmental Risks Acting on Body Weight · NA · not yet recruiting
- NCT07466498 — Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Canc · Phase 2 · not yet recruiting
- NCT06422299 — Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Youn · NA · not yet recruiting
- NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05455658 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Washington
- Last refreshed: 24 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05455658.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing