Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
Part of paid clinical trials in New Brunswick, New Jersey.
- Sponsor
- Rutgers, The State University of New Jersey
- Study ID
- NCT05736367
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- U-13C-glucose — DRUGDiscover new insights into the glucose, 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 U-13C-glucose-labeled biopsy of tumor and benign adjacent tissue
Study Details
To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.
Key Dates
- Start date
- Nov 15, 2024
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancerAdministration of U-13C-glucose to participants with early-stage HR+/Her2- breast cancer fitting criteria, will be done intraoperatively at the time of resection, as well as blood sample collection. This will allow for in depth evaluation of glycolysis as well as TCA cycle, lipid and amino acid metabolism and comprehensive genomic analyses to complement the metabolic assays that will be done by the Ludwig Institute of Cancer Research. HR+/Her2- breast cancer subtype is chosen for this feasibility pilot study given that metabolic studies have not been done in this subtype of breast cancer and it makes up the majority of breast cancer cases.
Primary Outcome Measure
Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS) [ Time Frame: Baseline to four weeks ]
Central Contacts
- Coral Omene, MD, PhD732-235-3374
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | |
| RWJBarnabas Health | New Brunswick | New Jersey | 08903 |
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