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.
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.
Eligibility
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.
