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.
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
Interventions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
OPC | Experimental | During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart. | |
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.
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: | Active, not recruiting |
Lead Sponsor: | Medical University of South Carolina |
Last Updated
January 8, 2021