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

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 tu

Trial Details

NCT ID
NCT07112053
Phase
PHASE2
Sponsor
University of Washington
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
  • Capecitabine
  • Computed Tomography
  • Cyclin-Dependent Kinase 4 Inhibitor
  • Cyclin-Dependent Kinase 6 Inhibitor
  • F-18 16 Alpha-Fluoroestradiol
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility 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 progesteron…
  • HER2-negative or HER2-low will be included and defined as:
  • 0-1+ HER2 expression by immunohistochemistry (IHC) OR

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Negative Breast Cancer Trials on Trialify →