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    Association details:
    Biomarker:PIK3CA mutation
    Cancer:Breast Cancer
    Drug:buparlisib (AN2025) (PI3K inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Biomed Res Int
    Title:

    Which Is the Most Appropriate PI3K Inhibitor for Breast Cancer Patients with or without PIK3CA Status Mutant? A Systematic Review and Network Meta-Analysis

    Published date:
    12/03/2020
    Excerpt:
    Nine eligible RCTs involving 3872 BC patients and four PI3K inhibitor therapy arms (i.e., alpelisib, buparlisib, pictilisib, and taselisib) were included....The PI3K inhibitors alpelisib and buparlisib appear to have superior efficacy and safety therapeutic choices for patients with BC, especially in PIK3CA-mutated patients.
    DOI:
    10.1155/2020/7451576
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    BKM120 in Cancers With PIK3CA Activating Mutations

    Excerpt:
    ...The PIK3CA mutation must be documented in a CLIA approved laboratory...
    Trial ID:
    NCT01501604
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer

    Excerpt:
    ...- Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status...
    Trial ID:
    NeoPHOEBE
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

    Excerpt:
    ...Overall Survival (OS) - Full Analysis Set (FAS)`Progression Free Survival (PFS) by PIK3CA Mutational Status`Overall Survival (OS) by PIK3CA Mutational Status`Overall Response Rate (ORR) by PIK3CA Mutational Status`Clinical Benefit Rate (CBR) by PIK3CA Mutational Status`Long-term Safety and Tolerability in the Two Treatment Arms - Safety Set (SS)`Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 1 Day 1 - Pharmacokinetic Analysis Set (PAS)`Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)`Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 - Full Analysis Set (FAS)`Time to Definitive Deterioration of ECOG Performance Status From Baseline - Full Analysis Set (FAS)...
    Trial ID:
    BELLE-3
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    BKM120 and Fulvestrant for Treating Postmenopausal Patients With Estrogen Receptor-Positive Stage IV Breast Cancer

    Excerpt:
    ...Examine the PIK3CA mutation status in circulating DNA at baseline thru last treatment...
    Trial ID:
    NCT01339442