The SOLTI-1507 IPATHER trial established 400 mg daily (21 days on, 7 days off) as the recommended phase 2 dose for ipatasertib when combined with trastuzumab and pertuzumab.
The combination therapy demonstrated a manageable safety profile, with diarrhea and nausea being the most common treatment-related adverse events.
Preliminary efficacy data are encouraging, showing a median progression-free survival of 16.4 months in a population with PIK3CA mutations, a known driver of resistance.
The study supports the feasibility of a chemo-free maintenance strategy targeting the PI3K/AKT pathway in HER2-positive metastatic breast cancer.
Background: The Challenge of PIK3CA Mutations in HER2-Positive Disease
