articleNew England Journal of MedicineMay 31, 2025Closed access

Overall Survival with Inavolisib in PIK3CA -Mutated Advanced Breast Cancer

Cornell University · Memorial Sloan Kettering Cancer Center · +16 more institutions

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Abstract

Background

-mutated, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who had had relapse during or within 12 months after completion of adjuvant endocrine therapy.

Methods

-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who had had disease recurrence or progression during or within 12 months after completion of adjuvant endocrine therapy to receive inavolisib plus palbociclib-fulvestrant (inavolisib group) or placebo plus palbociclib-fulvestrant (placebo group). In the current report, we provide the results of the final analysis of overall survival, including updated data on efficacy and safety.

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Funding