Status:
ACTIVE_NOT_RECRUITING
Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib
Lead Sponsor:
HealthPartners Institute
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, descriptive, single site, observational study in subjects receiving alpelisib for treatment of metastatic breast cancer. The purpose of the study is to characterize the impact o...
Eligibility Criteria
Inclusion
- Adults aged 18 or older with a diagnosis of metastatic breast cancer that are initiating treatment with alpelisib.
- Must be willing and able to comply with study visits and procedures.
- Must meet standard clinical criteria for utilization of alpelisib including hormone-receptor positive/HER2 negative cancer with the presence of a PIK3CA mutation.
- Oncologist plans to use alpelisib until progression of disease or unacceptable toxicity.
- Patients must receive cancer care during alpelisib treatment phase with a HealthPartners oncologist and be willing to see IDC/HealthPartners Diabetes Education for diabetes management.
- Must have a compatible smartphone, access to a compatible smartphone, or the ability to upload CGM reader from home or bring the reader in to a medical visit at least once a month for uploading, to allow for remote management of diabetes and data collection.
- Life expectancy of at least 3 months
Exclusion
- Known history of serious allergy to skin-adhesive material or previous cutaneous reaction to a continuous glucose monitor.
- Known currently uncontrolled diabetes, defined as the most recent HbA1c over 10% or history of DKA within 6 months prior to enrollment.
- Concurrent use of high-dose vitamin C, defined as ≥ 1g of oral vitamin C daily, or intravenous Vitamin C infusions.
- Any other concurrent severe and/or uncontrolled medical condition that, in the opinion of the investigator, would cause unacceptable safety risk, compromise compliance with the protocol, or contraindicate participation in the study. One example being known requirement for high dose steroids at the time of possible enrollment into the study.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06083038
Start Date
October 5 2023
End Date
March 1 2026
Last Update
December 31 2025
Active Locations (1)
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1
HealthPartners Cancer Research Center
Saint Louis Park, Minnesota, United States, 55426