AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: OPC

• Registration Number: NCT03092635
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Study Start: 2017-06-06
• Primary Completion: 2021-11-10
• Study Completion: 2022-04-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPC	OPC	During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart.

Primary Outcome Measures

Name	Time	Method
AGE level reduction	85 days	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 Outcome Measures

Name	Time	Method
Correlation between AGE level and A1C	85 days	Changes in AGE levels and A1C will be described using graphs and other models.
Correlation between AGE level and plasma IL6	85 days	Changes in AGE levels and IL6 will be described using graphs and other models.
Correlation between AGE level and leptin	85 days	Changes in AGE levels and leptin will be described using graphs and other models.
Correlation between AGE level and changes to BMI	85 days	Changes in AGE levels and BMI will be described using graphs and other models.
Correlation between AGE level and c-reactive protein (CRP)	85 days	Changes in AGE levels and CRP will be described using graphs and other models.
Correlation between AGE level and sRAGE (soluble receptor for AGE)	85 days	Changes in AGE levels and sRAGE will be described using graphs and other models.
Frequency of adverse events as assessed by CTCAE v. 4	85 days	Toxicities will be tabulated by type, grade and the visit at which they occurred.
Correlation between AGE level and quality of life	85 days	Measured by FACT-B quality of life questionnaire
Correlation between AGE level and oxLDLs (low density lipoprotein)	85 days	Changes in AGE levels and oxLDLs will be described using graphs and other models.
Correlation between AGE level and insulin resistance (HOMA-IR)	85 days	Changes in AGE levels and HOMA-IR will be described using graphs and other models.
Correlation between AGE level and lipids	85 days	Changes in AGE levels and lipids will be described using graphs and other models.
Correlation between AGE level and diet	85 days	Changes in AGE levels and diet will be described using graphs and other models. Diet will be assessed by using the NIH "Eating at America's Table Study Quick Food Scan" and the NCI "Quick Food Scan"
Correlation between AGE level and malondialdehyde (MDA)	85 days	Changes in AGE levels and MDA will be described using graphs and other models.
Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria	85 days	The anti-tumor response will be measured by comparing baseline and post-treatment imaging using RECIST 1.1 or MD Anderson criteria for bone only disease.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States