INAVO-120 (NCT04191499) is a phase III randomized study, where the association of inavolisib with palbociclib and fulvestrant was compared with that of placebo plus palbociclib and fulvestrant as a first-line treatment in subjects with PIK3CA-mutated, ER+/HER2− advanced, or relapsed breast cancer who had recurred during or within one year after adjuvant ET. This evidence concerns the gene PIK3CA and breast carcinoma.