Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative Breast Cancer

NCT03457779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-10-08

No results posted yet for this study

Summary

The primary objective is to describe and discover new insights into the glucose, amino acid, and lipid metabolic dependencies of TNBC via nuclear magnetic resonance (NMR) spectroscopy analysis of in vivo \[1,2-13C\] glucose-labeled breast cancer biopsies.

The secondary objectives are to correlate the dominant metabolic dependencies of TNBCs with pathologic response to preoperative chemotherapy, and with the cancers' molecular signaling pathways assessed via NGS and RPPA.

Conditions

Interventions

DIETARY_SUPPLEMENT

Glucose

The first 4 patients enrolled on trial will undergo the research core biopsies of their TNBC without the 13C glucose infusion; these samples will serve as control tissue that will be processed identically to the tissues obtained from patients who received the glucose isotope. The following 12 patients will receive 6 grams (g) of \[1,2-13C\] glucose as an IV

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Joyce O'Shaughnessy, MD · Texas Oncology/Baylor Scott & White Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2020-04-08
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457779 on ClinicalTrials.gov