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RECRUITING
NCT07817056

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-04-01

Completion Date

2028-10-31

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

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.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China