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NCT Number: NCT07817056

Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Yehui Shi, MD

CONTACT

[email protected]

18622221183

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risk-stratified hyperglycemia management strategy

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yehui Shi, Doctor of Medicine

CONTACT

[email protected]

18622221183

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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