A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer
University of Washington
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.
Description
OUTLINE: Patients with ET-sensitive disease are assigned to Cohort 1, while patients with ET-resistant disease are assigned to Cohort 2. COHORT 1: After completion of 2 cycles of standard of care (SOC) ET + CDK4/6 inhibitor (CDK4/6i) therapy or abemaciclib alone, patients receive STEMVAC intradermally (ID) on the following schedule: 1) Three "priming" doses every 28 days; 2) Two "booster" doses at 6 and 9 months after "priming" dose #1; and 3) Additional "booster" doses every 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo image-guided biopsies f…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must be at least ≥ 18 years of age * Histologically confirmed hormone receptor positive metastatic breast cancer: Tumors that are positive for estrogen receptor (ER) and/or progesterone receptor (PR) * HER2-negative or HER2-low will be included and defined as: * 0-1+ HER2 expression by immunohistochemistry (IHC) OR * Fluorescence in situ hybridization (FISH) negative OR * HER2 2+ and FISH negative * HER2 low per standard of care in breast cancer * Patients should be receiving the following therapies to be eligible for the study: * Cohort 1: First or…
Interventions
- BiologicalCD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
Given ID
- DrugCapecitabine
Given SOC capecitabine
- ProcedureComputed Tomography
Undergo CT or ultrasound-guided biopsies
- DrugCyclin-Dependent Kinase 4 Inhibitor
Given SOC CDK4/6i
- DrugCyclin-Dependent Kinase 6 Inhibitor
Given SOC CDK4/6i
- DrugF-18 16 Alpha-Fluoroestradiol
Undergo FES PET
- DrugHormone Therapy
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington