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    Association details:
    Biomarker:PIK3CA mutation + ER positive
    Cancer:HER2 Negative Breast Cancer
    Drug:Piqray (alpelisib) (PIK3CA inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer Discov
    Title:

    Alpelisib monotherapy for PI3K-altered, pre-treated advanced breast cancer: a phase 2 study

    Published date:
    06/30/2022
    Excerpt:
    We conducted a phase 2 multi-cohort study of alpelisib monotherapy in patients with advanced PI3K pathway mutant ER+HER2- and TNBC. In the intention to treat ER+ cohort, the overall response rate was 30% and the clinical benefit rate was 36%.
    DOI:
    10.1158/2159-8290.CD-21-1696
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2018
    Title:

    Plasma and tumor genomic correlates of response to BYL719 in PI3KCA mutated metastatic ER-positive breast cancer (ER+/HER2- BC)

    Published date:
    05/16/2018
    Excerpt:
    BYL719 in previously treated advanced ER+/HER2- BC with PIK3CA mt detectable in plasma at baseline demonstrated robust clinical benefit. 
    DOI:
    10.1200/JCO.2018.36.15_suppl.1055
    Trial ID:
    PIKNIC
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Breast Cancer Res
    Title:

    Targeting activated PI3K/mTOR signaling overcomes acquired resistance to CDK4/6-based therapies in preclinical models of hormone receptor-positive breast cancer

    Published date:
    08/14/2020
    Excerpt:
    Both alpelisib and fulvestrant exhibit efficacy either in single agent or in combination in ER+/HER2− xenografts harboring PIK3CA-mutant (MCF7) or PTEN-null (ZR751) tumors (Fig. 4a, b).
    Secondary therapy:
    fulvestrant
    DOI:
    10.1186/s13058-020-01320-8