^
    Evidence Level:
    Sensitive: A1 - Approval

    [PIK3CA mutation + HR positive-HER2 Negative Breast Cancer-alpelisib]

    Source:
    FDA
    Test:

    therascreen® PIK3CA RGQ PCR Kit

    Excerpt:
    PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
    Secondary therapy:
    fulvestrant
    Evidence Level:
    Resistant: C3 – Early Trials

    [PIK3CA mutation + HR positive-HER2 Negative Breast Cancer-CDK4 inhibitor + CDK6 inhibitor]

    Source:
    ESMO 2021
    Test:

    therascreen® PIK3CA RGQ PCR Kit

    Title:
    256P - PI3K mutation is associated with reduced sensitivity to CDK4/6 inhibitors in metastatic breast cancer
    Published date:
    09/13/2021
    Excerpt:
    The present study evaluated the incidence and distribution of de novo PIK3CA mutations in hormone receptor-positive / HER2-negative metastatic breast cancer (MBC) and its impact on clinical outcomes of patients treated with CDK4/6 inhibitors….PIK3CA mutation was associated with shorter progression-free survival (PFS) compared to PIK3CA wild type (18 versus 32.2 months, p-value 0.004)...