A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer

April 15, 2026 updated by: xuliang
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
inavolisib+ET
Drug: Inavolisib in Combination With ET
Inavolisib in Combination With ET
Inavolisib+CDK4/6i+ET
Drug: Inavolisib in Combination With ET+CDK4/6i
Inavolisib in Combination With ET+CDK4/6i

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 36 months
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)
From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months)
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
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.
From first prescription of inavolisib to disease progression or death from any cause, assessed for up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

xuliang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 16, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InavoRWS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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