An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 11 Aug 2018
At a glance
- Drugs Ribociclib (Primary) ; Anastrozole; Exemestane; Letrozole; Tamoxifen
- Indications Adenocarcinoma; Early breast cancer
- Focus Adverse reactions
- Acronyms EarLEE-1
- Sponsors Novartis Pharmaceuticals
- 23 Jul 2018 Protocol has been amended to change in Study design from Double blind to open ,change in Primary endpoint and Treatment arms.
- 27 Mar 2018 Planned End Date changed from 13 Sep 2023 to 25 Mar 2020.
- 27 Mar 2018 Planned primary completion date changed from 13 Sep 2023 to 25 Mar 2020.