← Back to Search

Metabolic Pathway Analysis

Metabolic Pathway Tracer for Breast Cancer

N/A
Waitlist Available
Led By Coral Omene, MD, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy).
Have hormone receptor (HR) positive [estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy.
Must not have
Concomitant active malignancy
Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to four weeks
Awards & highlights

Summary

This trial tests the effectiveness of a drug to treat HR+/Her2- breast cancer in terms of its metabolic activity.

Who is the study for?
This trial is for individuals with HR+/HER2- breast cancer, who haven't had neoadjuvant therapy and are set for curative surgery. They must be willing to provide tissue samples during surgery and not be part of another clinical study or have other active cancers.
What is being tested?
The trial studies how hormone receptor-positive, HER2-negative breast cancer cells process sugar by using a special form of glucose called U-13C-glucose during surgical resection of the tumor.
What are the potential side effects?
Since this study focuses on observing metabolic pathways rather than testing a drug, traditional side effects aren't expected. However, there may be risks associated with the biopsy procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a candidate for surgery to remove my cancer and have not had any pre-surgery treatments.
Select...
My breast cancer is hormone receptor positive and HER2 negative.
Select...
I agree to have small samples of my tumor and normal tissue taken during surgery for research.
Select...
My breast cancer is in an early stage (I, II, or III).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have another active cancer besides the one being treated.
Select...
My breast cancer is either triple negative or HER2 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to four weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)
Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm).
Secondary study objectives
Measure amino acid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS).
Measure amino acid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm)
Measure lipid metabolic dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancerExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Ludwig Institute for Cancer ResearchOTHER
61 Previous Clinical Trials
1,644 Total Patients Enrolled
4 Trials studying Breast Cancer
188 Patients Enrolled for Breast Cancer
Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,366 Total Patients Enrolled
15 Trials studying Breast Cancer
1,894 Patients Enrolled for Breast Cancer
Coral Omene, MD, PhDPrincipal InvestigatorCancer Institute of New Jersey Rutgers

Media Library

U-13C-glucose (Metabolic Pathway Analysis) Clinical Trial Eligibility Overview. Trial Name: NCT05736367 — N/A
Breast Cancer Research Study Groups: Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer
Breast Cancer Clinical Trial 2023: U-13C-glucose Highlights & Side Effects. Trial Name: NCT05736367 — N/A
U-13C-glucose (Metabolic Pathway Analysis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05736367 — N/A
~10 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top