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
Primary Objective: To evaluate the efficacy, in terms of Invasive Disease Free Survival(IDFS), for patientswith HR+, HER2- early stage breast cancer for:abemaciclib plus adjuvant endocrine therapy versusadjuvant endocrine therapy alone
Patient Population: patients with node-positive, early stage,hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer who completed definitive locoregional therapy (with or without neoadjuvant or adjuvant chemotherapy) and are at high risk for disease recurrence.
Target Accrual: 3580 patients
Status: Active, not recruiting participants
ClinicalTrials.gov Identifier: NCT03155997
The Mission of NSABP Foundation, Inc. is to design and conduct practice changing cancer research, including clinical trials and laboratory studies in the medical, surgical and prevention settings in order to improve the survival outcome and quality of life of patients with breast and colorectal cancer, and to disseminate the results of NSABP collaborative research to benefit the world-wide community.
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