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

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Metformin

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.