Breast Cancer, Diabetes
Conditions
Keywords
Breast Cancer, Alpelisib, hyperglycemia
Brief summary
The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days
Detailed description
AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.
Interventions
DEVICEFreeStyle Libre Pro
Measurements of interstitial glucose variations with FreeStyle Libre Pro
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women suffering breast cancer and eligible to treatment with Alpelisib 2. Age ≥18 years 3. Menopausal women (for at least 24 months) 4. Informed Consent Form signed
Exclusion criteria
1. Men 2. Pregnant ou child-bearing potential women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of hyperglycemia | Day 14 | In percentage, measured before breakfast and diner (fasting blood glucose). Hyperglycemia defined as follows: * if diabetes de novo: * capillar or interstitial fasting blood glucose ≥ 1,50 g/L, * OR postprandial interstitial glucose ≥ 2 g/L * OR glucose monitoring indicator ≥ 6,5% * if worsening pre-existing diabetes: * increased capillar or interstitial fasting blood glucose ≥ 0,50 g/L compared to average fasting blood glucose at J-3, J-2 and J-1 * AND postprandial interstitial glucose ≥ + 1,00 g/L compared to average fasting blood glucose at J-3, J-2 et J-1 OR average blood glucose ≥ +0,50 g/L |
Countries
France
Contacts
Primary ContactFatimata SARR SALL, PhD
Outcome results
None listed