Risk-stratified management of inavolisib-induced hyperglycemia in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, real-world study focuses on patients with HR+/HER2- advanced or metastatic breast cancer who carry a PIK3CA mutation and are starting inavolisib. Participants are managed with a risk-stratified hyperglycemia plan before treatment to prevent or reduce high blood sugar events. The goal is to see if personalized monitoring and interventions improve treatment adherence and clinical outcomes. Data are collected from electronic medical records, prescriptions, and lab results to assess safety, adherence, and effectiveness in routine practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Yehui Shi, Doctor of Medicine
• Email: shiyehui@tjmuch.com
• Phone: 18622221183

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.