A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE)
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)
Actual Study Start Date: December 7, 2018
Estimated Primary Completion Date: December 26, 2025
Estimated Study Completion Date: December 26, 2025
Arms:
- Experimental: Ribociclib + Endocrine Therapy
- Active Comparator: Endocrine Therapy
| Category | Value |
|---|---|
| Date last updated at source | 2019-07-11 |
| Study type(s) | Interventional |
| Expected enrolment | 4000 |
| Study start date | 2018-12-07 |
| Estimated primary completion date | 2025-12-26 |