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

NCT03457779 | Completed DMC

• 1 other identifier: 017-396
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Amount of glucose, amino acid, and lipid metabolites in TNBC.

  Amount of glucose, amino acid, lipid will be measured in 16 patients with TNBC using NMR spectroscopy to see how metabolism is affected in TNBC.

  2 years

Secondary Outcomes (1)

• Correlation of signaling pathways in TNBC with response and metabolites.

  2 years

Study Arms (2)

Non Glucose Arm

EXPERIMENTAL

4 patients without glucose infusion

Dietary Supplement: Glucose

Glucose Arm

EXPERIMENTAL

12 Patients with glucose infusion

Dietary Supplement: Glucose

Interventions

Glucose DIETARY_SUPPLEMENT

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

Glucose Arm; Non Glucose Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients ≥18 years of age.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient will be considered for enrollment in this study if all the following criteria are met:
• Female patients ≥18 years of age.
• Have TNBC defined as invasive ductal cancer: ER- tumors with \<10% of tumor nuclei immunoreactive; PR- tumors with \<10% of tumor nuclei immunoreactive; HER2-negative defined as follows:
• FISH-negative (FISH ratio \<2.0), or
• IHC 0-1+, or
• IHC 2+ AND FISH-negative (FISH ratio\<2.0)
• Adequate hematologic function, defined by:
• Absolute neutrophil count (ANC) \>1000/mm3
• Platelet count ≥100,000/mm3
• Hemoglobin \>9 g/dL (in the absence of red blood cell transfusion)
• Adequate liver function, defined by:
• AST and ALT ≤ 5 x the upper limit of normal (ULN)
• Total bilirubin ≤1.5 x ULN
• Adequate renal function, defined by:
• a. Serum creatinine ≤ 2 x ULN or calculated creatinine clearance of ≥60 ml/min

You may not qualify if:

• Patients receiving any anti-cancer therapy (chemotherapy, immunotherapy, and/or biologic therapy).
• 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 a history of insulin-dependent diabetes.
• Concomitant active malignancy
• Is pregnant or breastfeeding.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• Ghergurovich JM, Lang JD, Levin MK, Briones N, Facista SJ, Mueller C, Cowan AJ, McBride MJ, Rodriguez ESR, Killian A, Dao T, Lamont J, Barron A, Su X, Hendricks WPD, Espina V, Von Hoff DD, O'Shaughnessy J, Rabinowitz JD. Local production of lactate, ribose phosphate, and amino acids within human triple-negative breast cancer. Med. 2021 Jun 11;2(6):736-754. doi: 10.1016/j.medj.2021.03.009. Epub 2021 Apr 14.

  PMID: 34223403 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Glucose

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Joyce O'Shaughnessy, MD

  Texas Oncology/Baylor Scott & White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with TNBC will receive \[1,2-13C\]-glucose IV to prior to undergoing a biopsy of their breast cancer and blood collection to allow for in depth evaluation.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: March 8, 2018
• Study Start: February 8, 2018
• Primary Completion: April 8, 2020
• Study Completion: December 31, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be shared from opening of recruitment through study closure.
• Access Criteria: De-Identified Data will be shared via encrypted email

Locations

US (1)