Status:
COMPLETED
Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative Breast Cancer
Lead Sponsor:
Baylor Research Institute
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 v...
Detailed Description
One of the recognized hallmarks of cancer cells is deregulated cellular metabolism, characterized by enhanced metabolic autonomy compare with non-transformed cells. Tumor cells typically display an ov...
Eligibility Criteria
Inclusion
- 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
- Have blood glucose \<250 mg/dL
- Willing to undergo 1 mandatory core biopsy (6 passes) for research purposes.
- All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
Exclusion
- A patient will be ineligible for inclusion in this study any of the following criteria are met:
- 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.
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03457779
Start Date
February 8 2018
End Date
December 31 2020
Last Update
October 8 2021
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246