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A Phase II Exploratory, Open-label, Single Arm Study of BYL719 Monotherapy, a Selective Phosphatidylinositol 3-kinase (PI3K) Alpha Inhibitor, in Adult Patients With Advanced Breast Cancer Progressing After First Line Therapy

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Trial Profile

A Phase II Exploratory, Open-label, Single Arm Study of BYL719 Monotherapy, a Selective Phosphatidylinositol 3-kinase (PI3K) Alpha Inhibitor, in Adult Patients With Advanced Breast Cancer Progressing After First Line Therapy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Aug 2022

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At a glance

  • Drugs Alpelisib (Primary)
  • Indications Advanced breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Therapeutic Use
  • Acronyms PIKNIC

    • Most Recent Events

    • 22 Jun 2021 Status changed from recruiting to completed.
    • 05 Jun 2018 According to results presented at the 54th Annual Meeting of the American Society of Clinical Oncology, secondary endpoints of this trial also includes efficacy according to baseline and week 8 change in ctDNA levels.
    • 05 Jun 2018 Results (n=17) assessing the plasma and tumor genomic correlates of response to BYL719 in PI3KCA mutated metastatic ER-positive breast cancer (ER+/HER2- BC) patients, presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
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