Clinical Trials /

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

NCT03092635

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 102560
  • NCT ID: NCT03092635

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Metformin HydrochlorideMetformin + OPC

Purpose

The purpose of this study is to look at the effects that the study drugs (metformin and OPC) have 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 drugs (metformin and OPC) have an effect on the
      AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
    

Trial Arms

NameTypeDescriptionInterventions
Metformin + OPCExperimentalDuring week 1, subjects will take one metformin tablet in the morning and one OPC tablet in the morning and in the evening, about 12 hours apart. During weeks 2-12 the metformin tablet will be taken approximately 12 hours apart and one OPC about 12 hours apart, in the morning and in the evening.
  • Metformin Hydrochloride

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

          -  Known hypersensitivity or intolerance to metformin

          -  Any condition associated with increased risk of metformin-associated lactic acidosis
             (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class
             III or IV functional status; history of acidosis of any type; habitual intake of 3 or
             more alcoholic beverages per day).

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:AGE level reduction
Time Frame:85 days
Safety Issue:
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.

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Medical University of South Carolina

Last Updated

June 13, 2017