Clinical trial · Interventional
Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
NCT05736367CI-TRIAL-00101349recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| U-13C-glucose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer
- description
- 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.
- interventionNames
- Drug: U-13C-glucose
Primary outcomes (2)
- measure
- Measure glycolysis metabolism dependencies of hormone receptor positive/HER2 negative breast cancer using Liquid chromatography-mass spectrometry (LC-MS)
- timeFrame
- Baseline to four weeks
- description
- To analyze and describe the metabolism of these tumors in vivo uniformly-labeled (U-13C)-glucose-labeled biopsy of tumor and benign adjacent tissue. The participants will receive glucose infusion and their tumor specimens analyzed. Blood collection will allow for in depth evaluation of glycolysis metabolism. Compounds can range from low molecular mass analytes with m/z values \< 1000 Da, to very high molecular mass proteins with m/z values \> 100,000 Da U-13C-Glucose (study drug)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy. * Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0) * Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy). * Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection. Exclusion Criteria: * 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 triple negative (ER-/PR-/Her2-) or HER2+ breast cancer. * Concomitant active malignancy * Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)
References
Publications (0)
Data not yet available
No reference posted for this study.