An observational study in Breast Cancer and Hyperglycemia, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Observational
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
This study also gives Inavolisib. No intervention listed here names it: that was found by reading the record.
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 months
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.
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.
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.
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 months
Real-World Clinical Benefit Rate (rwCBR)
Percentage of participants who achieve complete response (CR), partial response (PR), or stable disease (SD), 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 months.
Incidence of Adverse Events Other Than Hyperglycemia
Incidence, severity, and categories of all non-hyperglycemia adverse events occurring after inavolisib administration, graded according to CTCAE v6.0.
Time frame: rom the start of inavolisib treatment until 30 days after treatment discontinuation, assessed up to approximately 24 months.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Oct 2027, 18 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 18 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
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Tianjin Medical University Cancer Institute and Hospital →