Clinical Trials Search
Clinical Trial 19393
Interventions:Abemaciclib; LY2835219 (Abemaciclib)
Study Type: Treatment
Phase of Study: Phase III
- Hung Khong
A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage,Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Primary Objective: To evaluate the efficacy, in terms of invasive disease-free survival (IDFS), as defined by the STEEP System, for patients with HR+, HER2- early stage breast cancer for abemaciclib 150 mg twice daily plus adjuvant endocrine therapy versus adjuvant endocrine therapy alone.