Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and Patient Adherence

Tianjin Medical University Cancer Institute and Hospital100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer Hyperglycemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of All-Grade Hyperglycemia Events

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)

Time frame: From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months

Secondary Outcomes

Incidence of Grade 3-4 Hyperglycemia in High-Risk Patients

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.

Time frame: From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months.

Real-World Time to Treatment Discontinuation

Defined as the time from the initiation date of inavolisib treatment to the date of permanent treatment discontinuation for any reason, or death

Time frame: From the initiation date of inavolisib until permanent treatment discontinuation or death from any cause, assessed up to approximately 24 months.

Real-World Progression-Free Survival

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.

Time frame: From the first prescription date of inavolisib until documented disease progression or death from any cause, assessed up to approximately 24 months.

Real-World Objective Response Rate (rwORR)

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.

Time frame: Assessed every 8 to 12 weeks from treatment initiation until disease progression, up to approximately 24 months

Real-World Clinical Benefit Rate (rwCBR)

Percentage of participants who achieve complete response (CR), partial response (PR), or stable disease (SD), evaluated by investigators according to RECIST criteria.

Time frame: Assessed every 8 to 12 weeks from treatment initiation until disease progression, up to approximately 24 months.

Incidence of Adverse Events Other Than Hyperglycemia

Incidence, severity, and categories of all non-hyperglycemia adverse events occurring after inavolisib administration, graded according to CTCAE v6.0.

Time frame: rom the start of inavolisib treatment until 30 days after treatment discontinuation, assessed up to approximately 24 months.