COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

Trial Profile

COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2017

At a glance

  • Drugs Goserelin (Primary) ; Letrozole (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer
  • Focus Adverse reactions
  • Acronyms CompLEEment-1
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals
  • Most Recent Events

    • 14 Sep 2017 Planned number of patients changed from 3000 to 3775.
    • 12 Sep 2017 Trial design presented at the 42nd European Society for Medical Oncology Congress
    • 21 Mar 2017 Planned End Date changed from 9 Nov 2020 to 14 May 2021.
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