A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy (FALCON).

Trial Profile

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy (FALCON).

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2017

At a glance

  • Drugs Fulvestrant (Primary) ; Anastrozole
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FALCON
  • Sponsors AstraZeneca
  • Most Recent Events

    • 09 Dec 2017 Results of FALCON, FIRST and CONFIRM studies comparing treatment effect of Fulvestrant vs comparators in post-menopausal patients, presented at the 40th Annual San Antonio Breast Cancer Symposium.
    • 28 Aug 2017 Based on the data from this trial, the US FDA has approved FASLODEX (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy.
    • 26 Jul 2017 According to an AstraZeneca media release, the European Commission (EC) approved Faslodex (fulvestrant) for the treatment of oestrogen-receptor positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The EU approval is based on pivotal data from this trial.
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