* eMonarcHER: Abemaciclib in Patients with Early Breast Cancer
Research type
Research Study
Full title
eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
IRAS ID
293935
Contact name
Stephen Johnston
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2020-004035-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Breast cancer is one of the most common cancers in women and a leading cause of cancer death in women worldwide. Hormone receptor positive (HR+), human epidermal growth factor receptor-2 positive (HER2+) breast cancer is one of the four main breast cancer subtypes. HR+, HER2+ means that tumour cells have these receptors on the surface of the breast cells. These receptors promote the growth of cancer cells. HER2+ breast cancer tends to be more aggressive, meaning that it grows and spreads faster, than cancer that doesn’t have HER2 receptors.
Many of HR+, HER2+ early breast cancer patients can be cured with currently available treatments: surgery, radiotherapy, chemotherapy and drugs that target the receptors such as hormone therapy (also called endocrine therapy) and HER2-targeted therapy. But about 25-30% will develop a recurrence either locally in the breast or elsewhere in the body.
The study drug, abemaciclib, is a tablet that works by blocking functions of certain proteins to help stop cancer cells from growing and dividing. Abemaciclib is an approved treatment for women with HR+, HER2- advanced or metastatic breast cancer as single agent therapy and in combination with endocrine therapy.
The study eMonarcHER will look at the potential for abemaciclib to enhance the benefits of endocrine therapy in patients with high-risk HR+, HER2+ early breast cancer who have completed their HER2-targeted therapy. There will be about 2,450 participants all around the world who will be taking part, including approximately 96 in the UK. Participants will be randomly put into treatment groups to receive either abemaciclib plus endocrine therapy or placebo plus endocrine therapy for approximately 2 years. Neither the participant nor the study doctor will know which treatment group a participant is in to avoid bias and to fully understand the effects of abemaciclib. Standard endocrine therapy will continue following participation in the study for a duration of an additional 3 to 8 years.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0150
Date of REC Opinion
12 Mar 2021
REC opinion
Further Information Favourable Opinion