Clinical trial · Interventional
Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
NCT05107388CI-TRIAL-00054877AARENunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FreeStyle Libre Pro | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Continuous interstitial glucose measurements
- description
- Variations of interstitial glucose are measured during 14 days with FreeStyle Libre Pro
- interventionNames
- Device: FreeStyle Libre Pro
Primary outcomes (1)
- measure
- Incidence rate of hyperglycemia
- timeFrame
- Day 14
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.