REMD 477 for Metastatic ER+ Breast Cancer with PIK3CA Mutation - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called REMD-477 (study drug) is a safe and effective treatment for people with metastatic ER+ breast cancer with PIK3CA mutation who developed high blood sugar while taking alpelisib.

What is the Condition Being Studied?

Metastatic ER+ Breast Cancer with PIK3CA mutation

Who Can Participate in the Study?

Adults with metastatic ER+ breast cancer who:
- Have a PIK3CA mutation
- Stopped treatment with alpelisib because of high blood sugar

For more information about who can join this study, please contact the study team at 919-660-1278.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Get injections under your skin of the study drug four times per month for three months
- Get an injection of fulvestrant once every four weeks
- Take alpelisib, as directed by your doctor
- Have blood draws
- Give us permission to use your tissue samples for research

We will schedule you to return to our clinic for a follow-up visit 30 days after your treatment ends.

Study Details

Full Title
A Pilot Study of Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit from PI3K Inhibitor Therapy: GRIP-IT Pilot
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00105104
NCT: NCT04330625
Phase
Phase Pilot
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698