Videos
PI3K Pathway Inhibition Improves Outcomes in Patients With Advanced Breast Cancer
05/08/2026
Clinical Summary:
- Design/Context: The phase 3 VIKTORIA-1 trial evaluating inavolisib plus fulvestrant with or without palbociclib versus fulvestrant alone in patients with HR-positive, HER2-negative metastatic breast cancer after CDK4/6 inhibitor therapy.
- Key Outcomes: Both the doublet and triplet regimens significantly improved progression-free survival compared with fulvestrant monotherapy in PIK3CA wild-type tumors.
- Clinical Relevance: These findings support PI3K pathway inhibition as a potential new second-line strategy in HR-positive metastatic breast cancer, particularly for patients without PIK3CA mutations.
Sara Hurvitz, MD, Fred Hutchinson Cancer Center, Seattle, Washington, discusses results from the phase 3 VIKTORIA-1 trial evaluating gedatolisib-based combinations among previously treated patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.
Results demonstrated that gedatolisib-based combinations significantly improve progression-free survival (PFS) with both doublet and triplet regimens compared with fulvestrant alone.
Source:
Hurvitz SA, Layman RM, Curigliano G, et al. VIKTORIA-1 trial of gedatolisib plus fulvestrant with or without palbociclib in hormone receptor-positive/HER2-/PIK3CA wild-type advanced breast cancer. J Clin Oncol. Published online: March 9, 2026. doi:10.1200/JCO-25-02643
