← 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to four weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to four weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ludwig Institute for Cancer ResearchOTHER

60 Previous Clinical Trials

1,604 Total Patients Enrolled

4 Trials studying Breast Cancer

188 Patients Enrolled for Breast Cancer

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,216 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research still open to recruiting volunteers?

"Information on clinicaltrials.gov indicates that this particular trial is not accepting applicants at the moment, despite its original posting date of June 15th 2023 and last edited date of February 16th 2023. However, over 2500 other trials are currently recruiting participants."

Answered by AI

Has the FDA authorized Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer?

"Our team at Power believes the safety of Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer to be a 1 due to this being a Phase 1 trial, meaning that there is limited data available on its safety and efficacy."

Answered by AI

What would success look like for this experimental venture?

"As the primary outcome, this trial will use Nuclear Magnetic Resonance (NMR) spectroscopy in parts per million (ppm) to evaluate glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer between Baseline and four weeks. To further analyze these tumors, Liquid chromatography-mass spectrometry (LC-MS) is also being employed to investigate lipid metabolic dependencies while NMR spectroscopy will be used for amino acid evaluation. Participants are required to receive a glucose infusion before having their tumor specimens analyzed together with a blood collection that allows an extensive analysis of both lipids and amino acids."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Coral Omene 2024. "Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05736367.