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    Association details:
    Biomarker:PIK3CA mutation + HR positive
    Cancer:HER2 Negative Breast Cancer
    Drug:Truqap (capivasertib) (AKT inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

    Published date:
    03/27/2024
    Excerpt:
    AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AstraZeneca Press Release
    Title:

    Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

    Published date:
    11/17/2023
    Excerpt:
    AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN)....The approval by the Food and Drug Administration (FDA) was based on the results from the CAPItello-291 Phase III trial...
    Secondary therapy:
    fulvestrant