Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
A Phase III, Multicenter, Open label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor positive/HER2 negative/HER2 Enriched Breast Cancer HARMONIA Trial
NCT Number:
NCT05207709
Phase:
III
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Breast
Study Objectives:
HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 80 sites worldwide.
Study Documents
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