Breast Cancer
Conditions
Keywords
PIK3CA mutation, breast cancer
Brief 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.
Interventions
DRUGInavolisib in Combination With ET
Inavolisib in Combination With ET
DRUGInavolisib in Combination With ET+CDK4/6i
Inavolisib in Combination With ET+CDK4/6i
Sponsors
xuliang
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Progression-Free Survival (rwPFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Stratified rwPFS for Cohort A and Cohort B | 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) | Up to approximately 36 months | — |
| Real-world Duration of Response (rwDoR) | From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months) | — |
Contacts
CONTACTliang Xu
Outcome results
None listed