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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inavolisib in Combination With ET

Drug

Inavolisib in Combination With ET

Inavolisib in Combination With ET+CDK4/6i

Drug

Inavolisib in Combination With ET+CDK4/6i

Primary outcomes

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.

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

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.
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)

Study contacts

Contact information is provided by the study sponsor or research team.

liang Xu

CONTACT

[email protected]

13691534938

Sponsors and collaborators

Lead sponsor

xuliang

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Apr 21, 2026
Registry last updated: Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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