Inavolisib Real-World Study for PIK3CA-Mutated Breast Cancer
Summary
NIH registered an observational study (NCT07543250) evaluating 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. The multicenter study will observe two treatment cohorts.
“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.”
What changed
NIH registered a new observational clinical trial through ClinicalTrials.gov. The study will observe the real-world effectiveness and safety of inavolisib in combination with endocrine therapy, with or without CDK4/6 inhibitor, in approximately 2,000 adult patients with HR-positive/HER2-negative, PIK3CA-mutated advanced breast cancer.
Healthcare providers and pharmaceutical sponsors should note this registry entry does not impose compliance obligations. It is an informational record of ongoing research. Patients seeking enrollment information may reference ClinicalTrials.gov identifier NCT07543250.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
Observational NCT07543250 Kind: OBSERVATIONAL Apr 21, 2026
Abstract
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
Interventions: Inavolisib in Combination With ET, Inavolisib in Combination With ET+CDK4/6i
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