This phase I trial tests the safety and effect of U-13C-glucose on metabolic activity in patients with early-stage hormone receptor positive (HR+), Her2 negative (Her2-) breast cancer that can be removed by surgery (resectable). Administration of intravenous (IV) glucose is a safe and informative approach to analysis of metabolic activity of breast cancer in its microenvironment. This trial could allow researchers to describe novel metabolic changes and dependencies in early-stage HR+, Her2- breast cancer that can be removed by surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT05736367.
Locations matching your search criteria
United States
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalStatus: Active
Contact: Coral Oghenerukevwe Omene
Phone: 732-235-3374
Rutgers Cancer Institute of New JerseyStatus: Active
Contact: Coral Oghenerukevwe Omene
Phone: 732-235-3374
PRIMARY OBJECTIVE:
I. To describe and discover new insights into the glucose, tricarboxylic acid (TCA) cycle, amino acid, and lipid metabolic dependencies of HR+/Her2- breast cancer, via liquid chromatography-mass spectrometry (LC-MS) and nuclear magnetic resonance (NMR) spectroscopy analysis of in vivo uniformly-labeled [13C] glucose (U-13C-glucose)-labeled biopsy of tumor and benign adjacent tissue.
OUTLINE:
Patients receive U-13C-glucose intravenously (IV), over 130 minutes, while undergoing standard of care resection surgery. Patients undergo blood sample collection on study.
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorCoral Oghenerukevwe Omene