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Metabolic Pathway Analysis

Metabolic Pathway Tracer for Breast Cancer

N/A

Recruiting

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

No Placebo-Only Group

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

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I am a candidate for surgery to remove my cancer and have not had any pre-surgery treatments.

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My breast cancer is hormone receptor positive and HER2 negative.

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I agree to have small samples of my tumor and normal tissue taken during surgery for research.

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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:

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I have another active cancer besides the one being treated.

Select...

My breast cancer is either triple negative or HER2 positive.

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met