Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and Patient Adherence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Risk-stratified hyperglycemia management strategy
Other interventionBaseline 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: High-Risk Group1 intervention
Group B: Low-Risk Group1 intervention
Trial outcomes
Primary outcomes
1
Incidence of All-Grade Hyperglycemia Events
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)
Time frame
From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 monthsSecondary outcomes
1
Incidence of Grade 3-4 Hyperglycemia in High-Risk Patients
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.
Time frame
From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months.2
Real-World Time to Treatment Discontinuation
Defined as the time from the initiation date of inavolisib treatment to the date of permanent treatment discontinuation for any reason, or death
Time frame
From the initiation date of inavolisib until permanent treatment discontinuation or death from any cause, assessed up to approximately 24 months.3
Real-World Progression-Free Survival
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.
Time frame
From the first prescription date of inavolisib until documented disease progression or death from any cause, assessed up to approximately 24 months.4
Real-World Objective Response Rate (rwORR)
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.
Time frame
Assessed every 8 to 12 weeks from treatment initiation until disease progression, up to approximately 24 monthsSponsors and contacts
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Source ClinicalTrials.gov