Breast CancerNCT05736367
Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
A study testing U-13C-glucose in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- U-13C-glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Coral Omene, MD,PhD, 732-235-3374, co273@cinj.rutgers.edu
- Not yet recruiting
RWJBarnabas Health
New Brunswick, New Jersey, 08903
Coral Omene, MD, PhD, 732-235-3374, co273@cinj.rutgers.edu
About this study
Official title: Pilot Study to Investigate 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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- U-13C-glucose
- Keywords
- Hormone Receptor Positive, Metabolic activity, Breast Cancer Surgery, 13C isotope glucose, Metabolomics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-13C-glucoseDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer | Experimental | 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. Receives: Drug: U-13C-glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)
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)
Measured: Baseline to four weeks
Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm).
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)
Measured: Baseline to four weeks
Secondary outcomes (4)
Measure lipid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)
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.
Measured: Baseline to four weeks
Measure lipid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm)
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.
Measured: Baseline to four weeks
Measure amino acid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS).
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
Measured: Baseline to four weeks
Measure amino acid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm)
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.
Measured: Baseline to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research
- Responsible party
- Principal investigator, Coral Omene, Rutgers, The State University of New Jersey
- Investigators
- Coral Omene, MD, PhD, Principal investigator, Cancer Institute of New Jersey Rutgers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736367
- Sponsor's protocol ID
- 042210
- Other IDs
- Pro2022002366
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05736367
- Acronym / sponsor ID
- 042210
- Conditions
- Breast Cancer
- Keywords
- Hormone Receptor Positive, Metabolic activity, Breast Cancer Surgery, 13C isotope glucose, Metabolomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer | Experimental | Drug: U-13C-glucoseAdministration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| U-13C-glucoseDiscover 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 | Drug | Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer |
Primary outcome
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)
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)
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Coral Omene, MD, PhD principal investigator
Cancer Institute of New Jersey Rutgers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-13C-glucose in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Coral Omene, MD, PhD (732-235-3374, co273@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.