A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation

Trial Profile

A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation

Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 07 Feb 2017

At a glance

  • Drugs Buparlisib (Primary) ; Paclitaxel
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms BELLE-4
  • Sponsors Novartis
  • Most Recent Events

    • 01 Nov 2016 Status changed from completed to discontinued according to results published in the Annals of Oncology as the study met protocol-specified criteria for futility in both populations, and phase III was not initiated and was stopped for futility at the end of phase II.
    • 01 Nov 2016 Results published in the Annals of Oncology
    • 09 Nov 2015 Results of an adaptive interim analysis (n=338) presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2015
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