Clinical trial NCT03092635: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: AGE level reduction
timeFrame: 85 days
Secondary outcomes:
measure: Correlation between AGE level and changes to BMI
timeFrame: 85 days
measure: Correlation between AGE level and insulin resistance (HOMA-IR)
timeFrame: 85 days
measure: Correlation between AGE level and A1C
timeFrame: 85 days
measure: Correlation between AGE level and lipids
timeFrame: 85 days
measure: Correlation between AGE level and diet
timeFrame: 85 days
measure: Correlation between AGE level and quality of life
timeFrame: 85 days
measure: Correlation between AGE level and plasma IL6
timeFrame: 85 days
measure: Correlation between AGE level and leptin
timeFrame: 85 days
measure: Correlation between AGE level and c-reactive protein (CRP)
timeFrame: 85 days
measure: Correlation between AGE level and malondialdehyde (MDA)
timeFrame: 85 days
measure: Correlation between AGE level and oxLDLs (low density lipoprotein)
timeFrame: 85 days
measure: Correlation between AGE level and sRAGE (soluble receptor for AGE)
timeFrame: 85 days
measure: Frequency of adverse events as assessed by CTCAE v. 4
timeFrame: 85 days
measure: Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria
timeFrame: 85 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael Lilly, MD
role: PRINCIPAL_INVESTIGATOR
References: