Breast Cancer, Hyperglycemia
Conditions
Keywords
Inavolisib, Risk Stratification, Hyperglycemia, Breast cancer
Brief summary
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.
Detailed description
The PI3K signaling pathway plays a crucial role in the occurrence and development of breast cancer. PI3K inhibitors, such as inavolisib, have been proven to significantly prolong progression-free survival (PFS) in patients with advanced HR+/HER2- breast cancer. However, inavolisib treatment is often accompanied by the adverse event of "hyperglycemia," which impacts patients' quality of life and long-term treatment adherence, and may ultimately interfere with the efficacy of the anti-tumor therapy. Therefore, how to manage this drug-related hyperglycemia has become an urgent issue to be resolved in clinical practice. Existing clinical trial data are insufficient to fully reflect the effectiveness of hyperglycemia management strategies in real-world clinical settings. This study will implement a pre-treatment risk-stratified management strategy. It aims to reduce the occurrence of adverse events through personalized management, ultimately prolong patients' treatment duration, decrease the incidence of hyperglycemia, and provide evidence-based support for clinical practice.
Interventions
OTHERRisk-stratified hyperglycemia management strategy
Baseline hyperglycemia risk is assessed using 5 factors (FPG, HbA1c, 2h PG, BMI, diabetes family history). High-risk patients (score ≥ 6) receive prophylactic metformin (initial 250 mg bid, titrated to 1000 mg bid), while low-risk patients (score ≤ 5) do not receive metformin pretreatment. Both groups receive standard inavolisib therapy with tailored monitoring.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All-Grade Hyperglycemia Events | From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months | Percentage of participants experiencing any-grade hyperglycemia events after receiving inavolisib treatment, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 6.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 3-4 Hyperglycemia in High-Risk Patients | From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months. | Percentage of participants in the high-risk cohort receiving prophylactic metformin who experience Grade 3 or 4 hyperglycemia events associated with inavolisib, graded according to CTCAE v6.0. |
| Real-World Time to Treatment Discontinuation | From the initiation date of inavolisib until permanent treatment discontinuation or death from any cause, assessed up to approximately 24 months. | Defined as the time from the initiation date of inavolisib treatment to the date of permanent treatment discontinuation for any reason, or death |
| Real-World Progression-Free Survival | From the first prescription date of inavolisib until documented disease progression or death from any cause, assessed up to approximately 24 months. | Defined as the time from the first prescription date of inavolisib to the first documented disease progression (assessed by investigators based on RECIST criteria) or death from any cause, whichever occurs first. |
| Real-World Objective Response Rate (rwORR) | Assessed every 8 to 12 weeks from treatment initiation until disease progression, up to approximately 24 months | Percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) maintained for at least 4 weeks, evaluated by investigators according to RECIST criteria. |
| Real-World Clinical Benefit Rate (rwCBR) | Assessed every 8 to 12 weeks from treatment initiation until disease progression, up to approximately 24 months. | Percentage of participants who achieve complete response (CR), partial response (PR), or stable disease (SD), evaluated by investigators according to RECIST criteria. |
| Incidence of Adverse Events Other Than Hyperglycemia | rom the start of inavolisib treatment until 30 days after treatment discontinuation, assessed up to approximately 24 months. | Incidence, severity, and categories of all non-hyperglycemia adverse events occurring after inavolisib administration, graded according to CTCAE v6.0. |
Countries
China
Contacts
CONTACTYehui Shi, Doctor of Medicine
STUDY_CHAIRYehui Shi, Doctor of Medicine
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed