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New drug inavolisib tested for Tough-to-Treat breast cancer

NCT ID NCT07347600

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This study looks at how well the drug inavolisib works for people with a certain type of advanced breast cancer that has a PIK3CA gene change and has stopped responding to hormone therapy. About 500 participants in China will receive inavolisib as part of their regular care. Researchers will track how long the cancer stays under control and any 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 500 people

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

Started

Jan 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants with endocrine-resistant, PIK3CA-mutated, HR+, HER2-, LA/mBC, following on or after completing adjuvant endocrine therapy in routine clinical practice 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: * Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy * Participants must receive the treatment of inavolisib for the first time * PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\] by testing of blood or tumor tissue prior to the initiation of inavolisib Exclusion Criteria: * Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant * Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling * At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Locally advanced breast cancer Metastatic breast cancer

How to take part

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

  1. The places running it

    30 sites. 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

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, 400030, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

  • Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)

    RECRUITING

    Lanzhou, Gansu, 730050, China

  • Guangdong Provincial Traditional Chinese Medicine Hospital

    RECRUITING

    Guangzhou, 510335, China

  • Guizhou Provincial People's Hospital

    RECRUITING

    Guiyang, 550002, China

  • Hainan Provincial Peoples Hospital

    RECRUITING

    Haikou, 570311, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, 150081, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, 450008, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, 430079, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, 210029, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, 330006, China

  • Liaoning cancer Hospital & Institute

    RECRUITING

    Shenyang, 110042, China

  • Luoyang Central Hospital

    RECRUITING

    Luoyang, 471000, China

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, 250021, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, 030013, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, 610072, China

  • Subei People's Hospital of Jiangsu province

    RECRUITING

    Yangzhou, 225001, China

  • Sun Yat-sen Memorial Hospital

    RECRUITING

    Guangzhou, 510120, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, 317000, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, 230022, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Xian Jiao Tong University

    RECRUITING

    Xi'an, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • Weifang People's Hospital

    RECRUITING

    Weifang, 261041, China

  • Wenzhou Medical University Affiliated Second Hospital

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • Zhongshan City People's Hospital

    RECRUITING

    Zhongshan, 528403, China

  • Zhongshan Hospital Fudan University

    RECRUITING

    Shanghai, 200032, China

  • Zhujiang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, 510280, China

More trials for these conditions

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