Protocol I3Y-MC-JPCF(d) 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.
monarchE is a Phase 3 study for patients with nodepositive, 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. The currently approved standards of care offered to this patient population are adjuvant cytotoxic chemotherapy and endocrine therapy. Despite advances in therapeutic options for early stage breast cancer, a high-risk subpopulation receives suboptimum benefit and may demonstrate resistance to anti-estrogen therapy at the time of recurrence. Therefore, improving the absolute benefit of adjuvant endocrine therapy is warranted in this high-risk subgroup given its cumulative rate of disease recurrence at 5 years is at least 15%. This Phase 3 study will evaluate the potential for abemaciclib to enhance standard adjuvant endocrine therapy compared to standard adjuvant endocrine therapy alone in patients with node-positive, early stage, resected HR+, HER2- breast cancer at high risk of disease recurrence.
Multi-centre randomised, open-label study that will 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.
Trial Length and Recruitment Aims at MBH
2 years or until discontinuation criteria met; we have one patient at MBH.