Breast CancerNCT07543250
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
An observational study of Breast Cancer, run by xuliang.
Trial summary
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Inavolisib in Combination With ET and Inavolisib in Combination With ET+CDK4/6i
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2026to 30 Jul 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer.
- Conditions
- Breast Cancer
- Being tested
- Inavolisib in Combination With ET, Inavolisib in Combination With ET+CDK4/6i
- Keywords
- PIK3CA mutation, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inavolisib in Combination With ETDrug
Inavolisib in Combination With ET
Inavolisib in Combination With ET+CDK4/6iDrug
Inavolisib in Combination With ET+CDK4/6i
| Study group | Role | What they receive |
|---|---|---|
| inavolisib+ET | Not described Receives: Drug: Inavolisib in Combination With ET | |
| Inavolisib+CDK4/6i+ET | Not described Receives: Drug: Inavolisib in Combination With ET+CDK4/6i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-World Progression-Free Survival (rwPFS)
Time from the index date (first prescription of inavolisib) to the first recorded disease progression (based on radiological or clinical assessment) or death from any cause, whichever occurs first.
Measured: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years
Secondary outcomes (3)
Stratified rwPFS for Cohort A and Cohort B
Time from the index date (first prescription of inavolisib) to the first recorded disease progression (based on radiological or clinical assessment) or death from any cause, whichever occurs first.
Measured: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately 36 months
Real-world Duration of Response (rwDoR)
Measured: From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start16 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xuliang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xuliang, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543250
- Sponsor's protocol ID
- InavoRWS
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625.
PubMed 39476340Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31.
PubMed 40454641Zhu R, Zhang H, Zhang F. Mechanistic optimization of inavolisib combined with CDK4/6 inhibitors in the treatment of PIK3CA-mutated breast tumors. Front Immunol. 2025 Nov 6;16:1693927. doi: 10.3389/fimmu.2025.1693927. eCollection 2025.
PubMed 41280894
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07543250
- Acronym / sponsor ID
- InavoRWS
- Conditions
- Breast Cancer
- Keywords
- PIK3CA mutation, breast cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- xuliangUniversity, hospital or other
- Study start
- 16 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 21 Apr 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.
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inavolisib+ET | – | Drug: Inavolisib in Combination With ET |
| Inavolisib+CDK4/6i+ET | – | Drug: Inavolisib in Combination With ET+CDK4/6i |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Inavolisib in Combination With ETInavolisib in Combination With ET | Drug | inavolisib+ET |
| Inavolisib in Combination With ET+CDK4/6iInavolisib in Combination With ET+CDK4/6i | Drug | Inavolisib+CDK4/6i+ET |
Primary outcome
Real-World Progression-Free Survival (rwPFS)
Time frame: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years
Time from the index date (first prescription of inavolisib) to the first recorded disease progression (based on radiological or clinical assessment) or death from any cause, whichever occurs first.
3 secondary outcomes
Stratified rwPFS for Cohort A and Cohort B
Time frame: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 36 months
Real-world Duration of Response (rwDoR)
Time frame: From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 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 21 Apr 2026.
- Results publication: PubMed 39476340Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625.
- Results publication: PubMed 40454641Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31.
- Results publication: PubMed 41280894Zhu R, Zhang H, Zhang F. Mechanistic optimization of inavolisib combined with CDK4/6 inhibitors in the treatment of PIK3CA-mutated breast tumors. Front Immunol. 2025 Nov 6;16:1693927. doi: 10.3389/fimmu.2025.1693927. eCollection 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by xuliang.
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 3 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: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 liang Xu (13691534938, liangxu15@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-World Progression-Free Survival (rwPFS) (time frame: From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07543250, which also lists 3 linked publications.
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 21 Apr 2026.