Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a simple risk score keep breast cancer patients on their targeted therapy?

NCT ID NCT07817056

Disease control Sponsor: Tianjin Medical University Cancer Institute and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Inavolisib treats certain PIK3CA-mutated, HR-positive, HER2-negative breast cancers but can raise blood sugar. Researchers at Tianjin Medical University Cancer Institute and Hospital are studying whether matching blood sugar monitoring and preventive metformin to each patient's risk level helps people stay on treatment. The study enrolls 100 adults starting inavolisib for the first time. It tracks high blood sugar events and how long patients continue the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inavolisib, a targeted breast cancer drug, plus a risk-based blood sugar management plan that may include metformin
What this could lead to
If the strategy works, doctors could use a simple risk score to decide who needs extra blood sugar protection, helping more patients stay on inavolisib and keep their cancer treatment on track.
What could go wrong
This is a small, real-world study of 100 people, not a randomized trial, so results may reflect local practice rather than the strategy itself. Metformin can cause stomach upset, and some patients may still develop serious high blood sugar or need to stop inavolisib.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer hyperglycemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Hyperglycemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.