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

NCT03092635 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 102560
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  85 days

Secondary Outcomes (14)

• Correlation between AGE level and changes to BMI

  85 days

• Correlation between AGE level and insulin resistance (HOMA-IR)

  85 days

• Correlation between AGE level and A1C

  85 days

• Correlation between AGE level and lipids

  85 days

• Correlation between AGE level and diet

  85 days

Study Arms (1)

OPC

EXPERIMENTAL

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

Drug: OPC

Interventions

OPC DRUG

OPC is a derivative of grape seed extract

OPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: June 6, 2017
• Primary Completion: November 10, 2021
• Study Completion: April 22, 2022
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)