Clinical trial · Interventional
AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy
Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
NCT03092635CI-TRIAL-00084332terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Original principal investigator departed institution and concluded the study upon departure.
Summary
Brief summary (as posted)
The purpose of this study is to look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic 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 |
|---|---|---|---|
| OPC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OPC
- description
- During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart.
- interventionNames
- Drug: OPC
Primary outcomes (1)
- measure
- AGE level reduction
- timeFrame
- 85 days
- description
- The primary objective is to determine if the test agents are able to reduce AGE levels by at least 30% in th 50% or more of test subjects.
Secondary outcomes (14)
- measure
- Correlation between AGE level and changes to BMI
- timeFrame
- 85 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have ER+ breast cancer * Metastatic disease; protocol does allow for bone-only disease * Must be receiving endocrine therapy * Must have completed at last 2 months of current endocrine therapy prior to registration * Must have adequate hematologic, renal and hepatic function * Prior/concurrent radiation therapy is allowed * Prior chemotherapy is allowed, but last dose must have been at least 2 months prior to enrollment * May have diabetes, but must not be taking metformin * Must be able to swallow and retain oral medication * Performance status of 0-2 * Treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications * Must be informed of the investigational nature of this study and must have the ability to sign informed consent. Exclusion Criteria: * Known allergy to grapes or grape seed * More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer. * Concurrent use of restricted agents outlined in section 4.5. * History of alcohol abuse within 2 years of registration.
References
Publications (0)
Data not yet available
No reference posted for this study.