A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

Official Title

A Phase III Multi-centre, 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-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Summary:

A phase III multi-centre, 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

Trial Description

Primary Outcome:

• Invasive Disease-Free Survival

• Recurrence-free survival
• Distant disease-free survival
• Overall Survival
• Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30
• Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30
• PK parameter Ctrough and other applicable parameters for ribociclib

View this trial on ClinicalTrials.gov