Clinical trial · Interventional
Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative Breast Cancer
Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative (TN) Breast Cancer and Associated Genomic Alterations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glucose | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Non Glucose Arm
- description
- 4 patients without glucose infusion
- interventionNames
- Dietary Supplement: Glucose
- type
- EXPERIMENTAL
- label
- Glucose Arm
- description
- 12 Patients with glucose infusion
- interventionNames
- Dietary Supplement: Glucose
Primary outcomes (1)
- measure
- Amount of glucose, amino acid, and lipid metabolites in TNBC.
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: A patient will be considered for enrollment in this study if all the following criteria are met: 1. Female patients ≥18 years of age. 2. 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: 1. FISH-negative (FISH ratio \<2.0), or 2. IHC 0-1+, or 3. IHC 2+ AND FISH-negative (FISH ratio\<2.0) 3. Adequate hematologic function, defined by: 1. Absolute neutrophil count (ANC) \>1000/mm3 2. Platelet count ≥100,000/mm3 3. Hemoglobin \>9 g/dL (in the absence of red blood cell transfusion) 4. Adequate liver function, defined by: 1. AST and ALT ≤ 5 x the upper limit of normal (ULN) 2. Total bilirubin ≤1.5 x ULN 5. Adequate renal function, defined by: a. Serum creatinine ≤ 2 x ULN or calculated creatinine clearance of ≥60 ml/min 6. Have blood glucose \<250 mg/dL 7. Willing to undergo 1 mandatory core biopsy (6 passes) for research purposes. 8. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry. Exclusion Criteria: A patient will be ineligible for inclusion in this study any of the following criteria are met: 1. Patients receiving any anti-cancer therapy (chemotherapy, immunotherapy, and/or biologic therapy). 2. 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. 3. Has a history of insulin-dependent diabetes. 4. Concomitant active malignancy 5. Is pregnant or breastfeeding.
References
Publications (1)
- DERIVEDGhergurovich 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