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-negartive 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
Secondary Outcome:
  • 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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society