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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OPC
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPC

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2017
Last Updated
August 9, 2022
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03092635
Brief Title
AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy
Official Title
Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Original principal investigator departed institution and concluded the study upon departure.
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPC
Arm Type
Experimental
Arm Description
During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart.
Intervention Type
Drug
Intervention Name(s)
OPC
Intervention Description
OPC is a derivative of grape seed extract
Primary Outcome Measure Information:
Title
AGE level reduction
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.
Time Frame
85 days
Secondary Outcome Measure Information:
Title
Correlation between AGE level and changes to BMI
Description
Changes in AGE levels and BMI will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and insulin resistance (HOMA-IR)
Description
Changes in AGE levels and HOMA-IR will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and A1C
Description
Changes in AGE levels and A1C will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and lipids
Description
Changes in AGE levels and lipids will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and diet
Description
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"
Time Frame
85 days
Title
Correlation between AGE level and quality of life
Description
Measured by FACT-B quality of life questionnaire
Time Frame
85 days
Title
Correlation between AGE level and plasma IL6
Description
Changes in AGE levels and IL6 will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and leptin
Description
Changes in AGE levels and leptin will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and c-reactive protein (CRP)
Description
Changes in AGE levels and CRP will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and malondialdehyde (MDA)
Description
Changes in AGE levels and MDA will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and oxLDLs (low density lipoprotein)
Description
Changes in AGE levels and oxLDLs will be described using graphs and other models.
Time Frame
85 days
Title
Correlation between AGE level and sRAGE (soluble receptor for AGE)
Description
Changes in AGE levels and sRAGE will be described using graphs and other models.
Time Frame
85 days
Title
Frequency of adverse events as assessed by CTCAE v. 4
Description
Toxicities will be tabulated by type, grade and the visit at which they occurred.
Time Frame
85 days
Title
Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria
Description
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.
Time Frame
85 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lilly, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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