A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

• Status: RECRUITING
• Trial end date: 2028-12-31

Summary

This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) or chemotherapy (CDK4/6 inhibitor or 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 are expressed on breast cancer stem cells, 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 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.

• Phase: PHASE2

Details

• Lead Sponsor: University of Washington
• Treatments: 16-fluoroestradiol; Biopsy; Capecitabine; Cyclin-Dependent Kinase Inhibitor p16; Cyclin-Dependent Kinase Inhibitor p18; High-Energy Shock Waves; Hormones; Magnetic Resonance Spectroscopy; Steroids