A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment

Trial Profile

A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2017

At a glance

  • Drugs Buparlisib (Primary) ; Fulvestrant
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms BELLE-3
  • Sponsors Novartis; Novartis Pharmaceuticals Corporation
  • Most Recent Events

    • 06 Dec 2017 Results assessing efficacy of buparlisib or placebo in combination with fulvestrant in patients with PIK3CA-mutant and wild-type status detected in ctDNA published in the Lancet Oncology
    • 27 Oct 2017 This trial has been discontinued in Netherlands (end date: 2017-09-08), according to European Clinical Trials Database record.
    • 26 Oct 2017 Results of analysis assessing role of PIK3CA mutation status as a biomarker of PI3K inhibitor treatment efficacy in pts with HR+, HER2- ABC using patient data from BELLE-2 and BELLE-3 trials presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2017
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