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NCT Number: NCT05736367

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

To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RWJBarnabas Health, New Brunswick, New Jersey, United States

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About this study

Participants will be asked to receive a glucose infusion (U-13C- glucose intravenous) during routine breast cancer surgery at which time, tumor biopsy samples and blood samples will be collected to be used in research experiments to help provide insight into the metabolic activity of the tumor. The length of time on study for each patient will be three - four weeks including two to three hours for glucose infusion and breast cancer biopsy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

U-13C-glucose

Drug

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

Primary outcomes

  1. 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

    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)

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

    Time frame: 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)

Secondary outcomes

  1. Measure lipid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)

    Time frame: 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 lipid metabolism.

  2. Measure lipid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm)

    Time frame: 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 lipid metabolism.

  3. Measure amino acid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS).

    Time frame: 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 amino acid 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

  4. Measure amino acid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm)

    Time frame: 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 amino acid metabolism.

Study contacts

Contact information is provided by the study sponsor or research team.

Coral Omene, MD, PhD

CONTACT

[email protected]

732-235-3374

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Ludwig Institute for Cancer Research

Registry information

Official study title

Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Feb 21, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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