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

September 8, 2026 updated by: Tianjin Medical University Cancer Institute and Hospital

A Multicenter, Real-World Study Evaluating the Impact of Risk-Stratified Management of Inavolisib-Related Hyperglycemia on Patient Adherence

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with PIK3CA-mutated, HR+/HER2- locally advanced or metastatic breast cancer receiving inavolisib in combination with endocrine therapy at participating oncology centers and hospitals in China.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-Risk Group
Patients with a baseline hyperglycemia risk score ≥ 6 who receive prophylactic metformin pretreatment alongside standard inavolisib plus endocrine therapy.
Other: Risk-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.
Low-Risk Group
Patients with a baseline hyperglycemia risk score ≤ 5 who receive standard inavolisib plus endocrine therapy without prophylactic metformin pretreatment
Other: Risk-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of All-Grade Hyperglycemia Events
Time Frame: 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)
From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade 3-4 Hyperglycemia in High-Risk Patients
Time Frame: 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.
From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months.
Real-World Time to Treatment Discontinuation
Time Frame: 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
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
Time Frame: 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.
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)
Time Frame: 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.
Assessed every 8 to 12 weeks from treatment initiation until disease progression, up to approximately 24 months
Real-World Clinical Benefit Rate (rwCBR)
Time Frame: 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.
Assessed every 8 to 12 weeks from treatment initiation until disease progression, up to approximately 24 months.
Incidence of Adverse Events Other Than Hyperglycemia
Time Frame: 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.
rom the start of inavolisib treatment until 30 days after treatment discontinuation, assessed up to approximately 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Study Chair: Yehui Shi, Doctor of Medicine, Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20260385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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