A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

Summary

The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.

Eligibility

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

Conditions4

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