^
    Back
    Association details:
    Biomarker:PIK3CA mutation
    Cancer:Solid Tumor
    Drug:Aliqopa (copanlisib) (PI3Kα inhibitor, PI3Kδ inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer

    Excerpt:
    ...- Patients must have had tumor sequencing for evaluation of actionable PIK3CA or PTEN mutations performed in a Clinical Laboratory Improvement Act (CLIA) certified, College of American Pathologist (CAP) tested and bioinformatics-validated testing lab PRIOR to enrollment in this current protocol....
    Trial ID:
    NCT03803761
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

    Excerpt:
    ...Genetic alterations will include PIK3CA gain of function mutations, PIK3R1 loss of function mutations, PTEN loss of function mutations, and PTEN deletions....
    Trial ID:
    NCT05082025
    More C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Phase II Study of Copanlisib in Patients With Tumors With PIK3CA Mutations: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1F

    Published date:
    02/08/2022
    Excerpt:
    Arm Z1F evaluated copanlisib, an α and δ isoform-specific phosphoinositide 3-kinase (PI3K) inhibitor, in patients with PIK3CA mutations (with or without PTEN loss)....The study met its primary end point with an ORR of 16% (P = .0341) with copanlisib showing clinical activity in select tumors with PIK3CA mutation in the refractory setting.
    DOI:
    10.1200/JCO.21.01648