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Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 2, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07112053). This is a study registration, not published results. Lead sponsor: University of Washington. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma. Interventions: BIOLOGICAL: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine; DRUG: Capecitabine; PROCEDURE: Computed Tomography; DRUG: Cyclin-Dependent Kinase 4 Inhibitor; DRUG: Cyclin-Dependent Kinase 6 Inhibitor; DRUG: F-18 16 Alpha-Fluoroestradiol; DRUG: Hormone Therapy; PROCEDURE: Positron Emission Tomography; PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; DRUG: Abemaciclib. Primary outcome measures: Incidence of adverse events (AEs) , Up to 3 years after completion of study treatment; Incidence of immunogenicity , Pre-vaccine up to after 2 booster doses of STEMVAC vaccine (Up to 40 weeks). Brief summary: This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4/6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with hormone receptor (HR)-positive, HER2-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that cancer 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. Standard ET is treatment that adds, blocks, or removes hormones in order to slow or stop the growth of cancer. Standard CDK4/6 inhibitors, including abemaciclib, may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.