A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer
Phase of Trial: Phase III
Latest Information Update: 10 Nov 2017
At a glance
- Drugs Ribociclib (Primary) ; Anastrozole; Exemestane; Letrozole; Tamoxifen
- Indications Adenocarcinoma; Breast cancer
- Focus Therapeutic Use
- Acronyms EarLEE-1
- Sponsors Novartis Pharmaceuticals
- 12 Sep 2017 Trial design presented at the 42nd European Society for Medical Oncology Congress
- 28 Jul 2017 Planned End Date changed from 21 Aug 2023 to 13 Sep 2023.
- 28 Jul 2017 Planned primary completion date changed from 21 Aug 2023 to 13 Sep 2023.