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NSABP B-58- MonarchE: Protocol I3Y-MC-JPCF

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