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 receptorpositive (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 receptorpositive (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: 26 Mar 2018

At a glance

  • Drugs Letrozole (Primary) ; Ribociclib (Primary) ; Goserelin
  • Indications Advanced breast cancer; Male 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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