^
    9ms
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
    P1/2; Phase classification: P2 --> P1/2
    Combination therapy • Phase classification • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
    |
    HER-2 positive • PIK3CA mutation
    |
    Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
    |
    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    over1year
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
    P2; Trial primary completion date: Jun 2023 --> Aug 2024
    Combination therapy • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
    |
    HER-2 positive • PIK3CA mutation
    |
    Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
    |
    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    over1year
    Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC (clinicaltrials.gov)
    P=N/A; Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> May 2023
    Trial completion date • Trial primary completion date • Enrollment closed • Diagnostic assay • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    therascreen® PIK3CA RGQ PCR Kit
    2years
    Detection of Somatic Variants in Breast Cancer Specimens Using the Novel AGENA ClearSEEK PIK3CA Panel on the MassARRAY System (AMP 2022)
    "The PI3K inhibitor alpelisib has been recently approved for the treatment of HR+/HER2- metastatic breast cancer with PIK3CA mutations (PIK3CAmut)... The AGENA ClearSEEK PIK3CA Panel combines both low DNA input and hands-on time requirements with accurate data assessment and provides a high-sensitive and reliable tool to perform PIK3CA analysis of clinically actionable mutations in breast cancer tumors."
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation • PIK3CA H1047R • PIK3CA E545K • PIK3CA E542K • PIK3CA E545 • PIK3CA E542
    |
    therascreen® PIK3CA RGQ PCR Kit • ClearSEEK™ PIK3CA Panel
    |
    Piqray (alpelisib)
    2years
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Combination therapy • Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
    |
    HER-2 positive • PIK3CA mutation
    |
    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
    |
    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    2years
    Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC (clinicaltrials.gov)
    P=N/A, N=120, Recruiting, Pharmassist Ltd | Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Apr 2021 --> Dec 2022
    Trial completion date • Trial primary completion date • Diagnostic assay • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    therascreen® PIK3CA RGQ PCR Kit
    over3years
    [VIRTUAL] PI3K mutation is associated with reduced sensitivity to CDK4/6 inhibitors in metastatic breast cancer (ESMO 2021)
    21 (58.6%) patients were on palbociclib and 15 (41.4%) on ribociclib along with endocrine therapy. The incidence and type of PIK3CA mutation is similar to the data reported previously. The presence of de novo PI3K mutation confers a worse clinical outcome in HR-positive / HER2 negative metastatic breast cancer patients despite use of CDK4/6 inhibitors. The presence of de novo PIK3CA mutation should be assessed upfront.
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative • PIK3CA exon 9 mutation + HR positive • CDK4 mutation
    |
    therascreen® PIK3CA RGQ PCR Kit
    |
    Ibrance (palbociclib) • Kisqali (ribociclib)
    over3years
    Patient acceptability of circulating tumour DNA testing in endometrial cancer follow-up. (PubMed, Eur J Cancer Care (Engl))
    "ctDNA monitoring to identify EC recurrence appears to be acceptable to patients, and for many, it may be preferable to clinical examination."
    Journal • Clinical
    |
    Guardant360® CDx • FoundationOne® Liquid CDx • cobas® EGFR Mutation Test v2 • therascreen® PIK3CA RGQ PCR Kit