Trial design
A randomised, open label, Phase 3 study of abemaciclib combined with standard adjuvant endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive, HER2 negative breast cancer.
The aim of this study, MonarchE, is to evaluate whether the combination of abemaciclib plus standard adjuvant endocrine therapy improves outcomes in participants with a certain type of breast cancer compared to adjuvant endocrine therapy alone.
Abemaciclib is an oral drug which stops the production of proteins in the body called CDK4 and CDK6, which are responsible for promoting cell growth. This mechanism and abemaciclib has been shown to have antitumour activity and significantly reduce tumour growth, including breast cancer.
This trial was specifically for patients (men as well as women) with node positive, early stage, hormone receptor positive, HER2 negative, invasive breast cancer and are at high risk of disease recurrence.
New Zealand centres for this trial were Auckland City, Waikato and Palmerston Hospitals.
This study is now closed (2023) and no more patients will be recruited. However, those already in the study will continue to be followed up.
Results
Researchers have now published a number of scientific papers describing results from this trial. These have demonstrated significant clinical benefit in adding abemaciclib to endocrine therapy for patients with high risk, node positive, early stage, hormone receptor positive, HER2 negative breast cancer.
The most recent publication (January 2023) showed that adding abemaciclib to endocrine therapy reduced the risk of recurrence of invasive disease by 32% and the risk of metastatic recurrence by 33%. (Toi M, Boyle F, Im YH, Reinisch M, Molthrop D, Jiang Z, Wei R, Sapunar F, Grimes BR, Nabinger SC, Johnston SRD. Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1. Oncologist. 2023 Jan 18;28(1):e77-e81. doi: 10.1093/oncolo/oyac234. PMID: 36342342; PMCID: PMC9847542.) You can read this research paper here.
