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New drug combo targets tough breast cancer in Real-World study

NCT ID NCT07543250

Disease control Sponsor: xuliang Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how well a drug called inavolisib works in real-world settings for people with a certain type of advanced breast cancer (HR-positive, HER2-negative, with a PIK3CA mutation). About 100 participants will take inavolisib along with hormone therapy, sometimes with another drug. Researchers will track how long the cancer stays under control and any side effects.

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 cancer drug) combined with endocrine therapy, with or without a CDK4/6 inhibitor
What this could lead to
If successful, this could provide a new treatment option for people with a specific type of advanced breast cancer, potentially slowing disease progression.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also early-stage and may not show clear benefits or may have side effects.

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.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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

HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer

Ages

18 years and older

Sex

Female participants only

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: * Histologically or cytologically confirmed HR+/HER2- recurrent or metastatic breast cancer. * Presence of a pathogenic PIK3CA mutation confirmed by tissue or plasma-based NGS/PCR testing. * Availability of traceable electronic medical records, imaging, laboratory, and follow-up data at baseline. * Initiated treatment with "Inavolisib + Endocrine Therapy" with or without a CDK4/6 inhibitor in real-world clinical practice, with complete and traceable regimen information. * Provision of informed consent for this non-interventional study (if required by the center's ethics committee). Exclusion Criteria: * Concurrent participation in any interventional clinical trial at enrollment. * Presence of another active malignancy requiring concurrent systemic therapy, or missing core data preventing outcome assessment. * Any condition (psychiatric, social, geographical) that would preclude adequate follow-up, as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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