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: 11 Jan 2018

At a glance

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

    • 11 Jan 2018 According to trial designed presented at 40th annual San Antonio Breast Cancer Symposium (SABCS), first 57 patient are enrolled.
    • 11 Jan 2018 Trial design was presented at 40th annual San Antonio Breast Cancer Symposium (SABCS).
    • 14 Nov 2017 According to a Novartis media release, data from this trial will be presented at the upcoming 40th annual San Antonio Breast Cancer Symposium (SABCS).
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