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Investigating Metabolic Pathways in HR+/HER2- Breast Cancer

This study is looking into how hormone receptor positive (HR+)/HER2 negative (HER2-) breast cancer uses energy. Researchers want to understand the cancer's "metabolic dependencies" using a special type of sugar called U-13C-glucose. You might be able to join if you have early-stage HR+/HER2- breast cancer that hasn't been treated yet and you're scheduled for surgery. The study will measure how the cancer uses sugar (glycolysis metabolism) to grow. This information could help doctors find new ways to treat this type of breast cancer. The study plans to enroll 16 participants, but its current status is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 16 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive a U-13C-glucose infusion during your routine breast cancer surgery. Tumor biopsy and blood samples would be collected during this time. The total time on study is three to four weeks, including a two to three hour infusion and biopsy.
Compensation
Not stated in the trial record.
Follow-up
Glycolysis metabolism dependencies will be measured from baseline to four weeks after the intervention.

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NCT05736367

Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer

Recruiting
NAAges 18+InterventionalBasic science
Rutgers, The State University of New Jersey
~16 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:U-13C-glucose

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)
Measured over Baseline to four weeks
+1 more outcome measured

Conditions

Breast Cancer

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Where it's being run

2 sites across 1 states
New Jersey2

Study leadership

  • Coral Omene, MD, PhD · PRINCIPAL_INVESTIGATOR · Cancer Institute of New Jersey Rutgers

Who to contact

Coral Omene, MD, PhD
[email protected]
732-235-3374
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy.
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

Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.
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)

What this trial measures

  • Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)Baseline to four weeks

    To analyze and describe the metabolism of these tumors in vivo uniformly-labeled (U-13C)-glucose-labeled biopsy of tumor and benign adjacent tissue. The participants will receive glucose infusion and their tumor specimens analyzed. Blood collection will allow for in depth evaluation of glycolysis metabolism. Compounds can range from low molecular mass analytes with m/z values \< 1000 Da, to very high molecular mass proteins with m/z values \> 100,000 Da U-13C-Glucose (study drug)

  • Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm).Baseline to four weeks

    To analyze and describe the metabolism of these tumors in vivo uniformly-labeled (U-13C)-glucose-labeled biopsy of tumor and benign adjacent tissue. The participants will receive glucose infusion and their tumor specimens analyzed. Blood collection will allow for in depth evaluation of glycolysis metabolism. U-13C-Glucose (study drug)