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

Phase 1TerminatedNCT03092635

Medical University of South Carolina9 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

OPCDRUG

OPC is a derivative of grape seed extract

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 85 days

Secondary Outcomes

Correlation between AGE level and changes to BMI

Changes in AGE levels and BMI will be described using graphs and other models.

Time frame: 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.

Time frame: 85 days

Correlation between AGE level and A1C

Changes in AGE levels and A1C will be described using graphs and other models.

Time frame: 85 days

Correlation between AGE level and lipids

Changes in AGE levels and lipids will be described using graphs and other models.

Time frame: 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"

Time frame: 85 days

Correlation between AGE level and quality of life

Measured by FACT-B quality of life questionnaire

Time frame: 85 days

Correlation between AGE level and plasma IL6

Data from ClinicalTrials.gov

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