Clinical trial · Observational
Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and Patient Adherence
A Multicenter, Real-World Study Evaluating the Impact of Risk-Stratified Management of Inavolisib-Related Hyperglycemia on Patient Adherence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
Inavolisib is an effective targeted therapy for certain patients with breast cancer, but it may cause high blood sugar (hyperglycemia) as a side effect. This multicenter, real-world study aims to evaluate whether implementing a risk-stratified management strategy for inavolisib-related hyperglycemia can positively impact patients' adherence to their treatment. By categorizing patients based on their blood sugar risk levels and applying corresponding management plans, researchers hope to improve medication compliance and overall clinical outcomes in real-world clinical practice.
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 |
| Hyperglycemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Risk-stratified hyperglycemia management strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- High-Risk Group
- description
- Patients with a baseline hyperglycemia risk score ≥ 6 who receive prophylactic metformin pretreatment alongside standard inavolisib plus endocrine therapy.
- interventionNames
- Other: Risk-stratified hyperglycemia management strategy
- label
- Low-Risk Group
- description
- Patients with a baseline hyperglycemia risk score ≤ 5 who receive standard inavolisib plus endocrine therapy without prophylactic metformin pretreatment
- interventionNames
- Other: Risk-stratified hyperglycemia management strategy
Primary outcomes (1)
- measure
- Incidence of All-Grade Hyperglycemia Events
- timeFrame
- From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older at the time of signing the informed consent form * Diagnosed with PIK3CA-mutated, hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. * Confirmed PIK3CA mutation status in blood or tumor tissue using NMPA-approved or adequately validated testing methods (PCR or NGS) prior to initiating inavolisib therapy. * First-time recipient of inavolisib treatment. * The study center can provide complete electronic medical records, prescription records, and laboratory test data. Exclusion Criteria: * Concomitant history of recent severe metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state. * Prior participation in any clinical trial where adverse events experienced during that trial have not resolved or stabilized prior to starting inavolisib (as determined by the investigator). * Currently participating in any other clinical study or trial that prohibits concurrent participation in this study. * Any condition or reason that, in the opinion of the investigator, makes the patient unsuitable for study participation or difficult to follow up.
References
Publications (0)
Data not yet available