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
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
- 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.