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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 of alpelisib on glucose control in patients with breast cancer using continuous glucose monitoring to measure glucose levels throughout the day and night. Patients will follow a hyperglycemia prevention and management regimen aimed to diminish hyperglycemia known to occur in most oncology patients starting alpelisib.
All patients will wear an Abbott FreeStyle Libre 2 system to obtain continuous glucose monitor (CGM) data (glucose measured every minute for 14 days). CGM will be placed at least 10 days prior to starting alpelisib and continue for at least 3 months while taking alpelisib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic breast cancer starting alpelisib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpelisib | Drug | Patients will receive standard of care alpelisib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak glucose level following the administration of alpelisib | Time (hr., min.) from taking alpelisib to the peak of the median glucose line of the standardize AGP/CGM report from day 21-28 after start of alpelisib. (calculated as- the average time to peak glucose on 7-day AGP profile minus avg time taking alpelisib). Primary outcome is time to peak glucose for all patients on alpelisib combined | Up to 28 days after start of alpelisib |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects scheduled to receive standard of care alpelisib for treatment of metastatic breast cancer.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Cancer Research Center | Saint Louis Park | Minnesota | 55426 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C585539 | Alpelisib |
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| FreeStyle Libre 2 Continuous Glucose Monitor | Device | All patients will wear Abbott FreeStyle Libre 2 system to obtain CGM data (glucoses measured every minute for 14 days). CGM monitors will be placed at least 10 days prior to starting alpelisib and continue CGM for at least 3 months while taking alpelisib. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |