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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Symptomatic restrictive cardiomyopathy

Trial design

Treatments tested in this trial

  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
  • Recombinant Granulocyte-Macrophage Colony-Stimulating Factor
  • Biospecimen Collection

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

United States Department of Defense

Collaborator