Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
NCT ID: NCT05736367
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2024-11-15
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer
Administration 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.
U-13C-glucose
Discover 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
Interventions
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U-13C-glucose
Discover 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
Eligibility Criteria
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Inclusion Criteria
* Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0)
* Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy).
* Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection.
Exclusion Criteria
* Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer.
* Concomitant active malignancy
* Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)
18 Years
ALL
No
Sponsors
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Ludwig Institute for Cancer Research
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Coral Omene
Assistant Professor, Medical Oncology, Rutgers Cancer Institute of New Jersey
Principal Investigators
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Coral Omene, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute of New Jersey Rutgers
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health
New Brunswick, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro2022002366
Identifier Type: OTHER
Identifier Source: secondary_id
042210
Identifier Type: -
Identifier Source: org_study_id