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First-line inavolisib/placebo + palbociclib + fulvestrant (Inavo/Pbo+Palbo+Fulv) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2negative locally advanced/metastatic breast cancer who relapsed during/within 12 months (mo) of adjuvant endocrine therapy completion: INAVO120 Phase III randomized trial additional analyses

Use with caution in pregnant or lactating animals as safe use has not been established in this population SAMe has a wide safety margin

These may include changes in gastrointestinal function, such as altered bowel habits and metabolic effects