Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT03092635
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03092635
Study Brief:
Protocol Section:
NCT03092635