Breast CancerNCT07817056
Risk-Stratified Management of Inavolisib-Induced Hyperglycemia and Patient Adherence
An observational study of Breast Cancer and Hyperglycemia, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Hyperglycemia
- What is being tested?
- Risk-stratified hyperglycemia management strategy
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Yehui Shi, MD, 18622221183, shiyehui@tjmuch.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Hyperglycemia
- Being tested
- Risk-stratified hyperglycemia management strategy
- Keywords
- Inavolisib, Risk Stratification, Hyperglycemia, Breast cancer
- Medical subject headings
- Breast Neoplasms, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-stratified hyperglycemia management strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Risk Group | Patients with a baseline hyperglycemia risk score ≥ 6 who receive prophylactic metformin pretreatment alongside standard inavolisib plus endocrine therapy. Receives: Other: Risk-stratified hyperglycemia management strategy | |
| Low-Risk Group | Patients with a baseline hyperglycemia risk score ≤ 5 who receive standard inavolisib plus endocrine therapy without prophylactic metformin pretreatment Receives: Other: Risk-stratified hyperglycemia management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From the start of inavolisib treatment until treatment discontinuation or disease progression, assessed up to approximately 12 months
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: rom the start of inavolisib treatment until 30 days after treatment discontinuation, assessed up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Apr 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yehui Shi, Doctor of Medicine, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817056
- Sponsor's protocol ID
- E20260385
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Real-World Study Evaluating the Impact of Risk-Stratified Management of Inavolisib-Related Hyperglycemia on Patient Adherence
- ClinicalTrials.gov ID
- NCT07817056
- Acronym / sponsor ID
- E20260385
- Conditions
- Breast Cancer, Hyperglycemia
- Keywords
- Inavolisib, Risk Stratification, Hyperglycemia, Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Risk Group | – | Other: Risk-stratified hyperglycemia management strategyPatients with a baseline hyperglycemia risk score ≥ 6 who receive prophylactic metformin pretreatment alongside standard inavolisib plus endocrine therapy. |
| Low-Risk Group | – | Other: Risk-stratified hyperglycemia management strategyPatients with a baseline hyperglycemia risk score ≤ 5 who receive standard inavolisib plus endocrine therapy without prophylactic metformin pretreatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-stratified hyperglycemia management strategyBaseline 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. | Other | High-Risk Group, Low-Risk Group |
Primary outcome
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)
6 secondary outcomes
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.
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.
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yehui Shi, Doctor of Medicine study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Hyperglycemia, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yehui Shi, Doctor of Medicine (18622221183, shiyehui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.