NCT05736367

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
26mo left

Started Nov 2024

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Nov 2024Jun 2028

First Submitted

Initial submission to the registry

February 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

February 6, 2023

Last Update Submit

January 17, 2026

Conditions

Breast Cancer

Keywords

Hormone Receptor PositiveMetabolic activityBreast Cancer Surgery13C isotope glucoseMetabolomics

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    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)

    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)

    Baseline to four weeks

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

    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)

    Baseline to four weeks

Study Arms (1)

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.

Drug: U-13C-glucose

Interventions

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

Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

RWJBarnabas Health

New Brunswick, New Jersey, 08903, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Coral Omene, MD, PhD

    Cancer Institute of New Jersey Rutgers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Coral Omene, MD, PhD

CONTACT

732-235-3374co273@cinj.rutgers.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Medical Oncology, Rutgers Cancer Institute of New Jersey

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 21, 2023

Study Start

November 15, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2028

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)