A phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of inavolisib in combination with phesgo versus placebo in combination with phesgo as maintenance therapy after first line induction therapy in participants with pik3ca‑mutated her2‑positive locally advanced or metastatic breast cancer- WO44263 (INAVO122).

PI: Giulia Bianchi

A Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of inavolisib in combination with RO7198574 (ARM A) versus placebo in combination with RO7198574 (ARM B) as maintenance therapy after first-line induction therapy in participants with PIK3CA-mutated, locally advanced or metastatic HER2-positive breast cancer.  

All participants will then receive chemotherapy with a type of drug called a taxane and a HER2-targeted therapy consisting of the combination of trastuzumab and pertuzumab (given intravenously or subcutaneously) or RO7198574. This combination of drugs is one of the regular and approved treatments for patients diagnosed with HER2-positive breast cancer and is called the “standard of care.”