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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: OPC

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPC; During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart.	Drug: OPC; OPC is a derivative of grape seed extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AGE level reduction	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.	85 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between AGE level and changes to BMI	Changes in AGE levels and BMI will be described using graphs and other models.	85 days
Correlation between AGE level and insulin resistance (HOMA-IR)	Changes in AGE levels and HOMA-IR will be described using graphs and other models.	85 days
Correlation between AGE level and A1C	Changes in AGE levels and A1C will be described using graphs and other models.	85 days
Correlation between AGE level and lipids	Changes in AGE levels and lipids will be described using graphs and other models.	85 days
Correlation between AGE level and diet	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"	85 days
Correlation between AGE level and quality of life	Measured by FACT-B quality of life questionnaire	85 days
Correlation between AGE level and plasma IL6	Changes in AGE levels and IL6 will be described using graphs and other models.	85 days
Correlation between AGE level and leptin	Changes in AGE levels and leptin will be described using graphs and other models.	85 days
Correlation between AGE level and c-reactive protein (CRP)	Changes in AGE levels and CRP will be described using graphs and other models.	85 days
Correlation between AGE level and malondialdehyde (MDA)	Changes in AGE levels and MDA will be described using graphs and other models.	85 days
Correlation between AGE level and oxLDLs (low density lipoprotein)	Changes in AGE levels and oxLDLs will be described using graphs and other models.	85 days
Correlation between AGE level and sRAGE (soluble receptor for AGE)	Changes in AGE levels and sRAGE will be described using graphs and other models.	85 days
Frequency of adverse events as assessed by CTCAE v. 4	Toxicities will be tabulated by type, grade and the visit at which they occurred.	85 days
Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria	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.	85 days

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Michael Lilly, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 102560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No