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

January 3, 2025 updated by: Medical University of South Carolina

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AGE level reduction
Time Frame: 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.
85 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between AGE level and changes to BMI
Time Frame: 85 days
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)
Time Frame: 85 days
Changes in AGE levels and HOMA-IR will be described using graphs and other models.
85 days
Correlation between AGE level and A1C
Time Frame: 85 days
Changes in AGE levels and A1C will be described using graphs and other models.
85 days
Correlation between AGE level and lipids
Time Frame: 85 days
Changes in AGE levels and lipids will be described using graphs and other models.
85 days
Correlation between AGE level and diet
Time Frame: 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"
85 days
Correlation between AGE level and quality of life
Time Frame: 85 days
Measured by FACT-B quality of life questionnaire
85 days
Correlation between AGE level and plasma IL6
Time Frame: 85 days
Changes in AGE levels and IL6 will be described using graphs and other models.
85 days
Correlation between AGE level and leptin
Time Frame: 85 days
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)
Time Frame: 85 days
Changes in AGE levels and CRP will be described using graphs and other models.
85 days
Correlation between AGE level and malondialdehyde (MDA)
Time Frame: 85 days
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)
Time Frame: 85 days
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)
Time Frame: 85 days
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
Time Frame: 85 days
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
Time Frame: 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.
85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Lilly, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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