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    Association details:
    Biomarker:PIK3CA mutation
    Cancer:Triple Negative Breast Cancer
    Drug:ipatasertib (RG7440) (PI3K inhibitor, AKT inhibitor)
    Direction:Resistant
    Evidence:
    Evidence Level:
    Resistant: B - Late Trials
    New
    Source:
    SABCS 2020
    Title:

    GS3-04 Double-blind placebo (PBO)-controlled randomized phase III trial evaluating first-line ipatasertib (IPAT) combined with paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer (aTNBC): primary results from IPATunity130 Cohort A

    Published date:
    10/12/2020
    Excerpt:
    Treatment with ipatasertib plus paclitaxel (Abraxane) failed to show a significant improvement in progression-free survival versus placebo plus paclitaxel in patients with PIK3CA/AKT1/PTEN-altered locally advanced, unresectable, or metastatic triple-negative breast cancer.
    Secondary therapy:
    albumin-bound paclitaxel
    Trial ID:
    IPATunity130
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130)

    Excerpt:
    ...Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status...
    Trial ID:
    IPATunity130
    Evidence Level:
    Resistant: C3 – Early Trials
    Source:
    ESMO-BC-I 2020
    Title:

    139O - Final results of the double-blind placebo (PBO)-controlled randomised phase II LOTUS trial of first-line ipatasertib (IPAT) + paclitaxel (PAC) for inoperable locally advanced/metastatic triple-negative breast cancer (mTNBC)

    Published date:
    05/23/2020
    Excerpt:
    CONTRADICTING EVIDENCE: In the ITT population, median OS was numerically longer in the IPAT + PAC arm (Table). Similarly, median OS favoured IPAT + PAC vs PBO + PAC in the PTEN-low (n=48; 23.1 vs 15.8 mo) and PIK3CA/AKT1/PTEN-altered (n=42; 25.8 vs 22.1 mo) subgroups.
    Secondary therapy:
    paclitaxel
    Trial ID:
    LOTUS