MonarchE: Phase 3 Study of Abemaciclib in Breast Cancer (JPCF)
Research type
Research Study
Full title
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
IRAS ID
226685
Contact name
Héléne Carmelez
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-004362-26
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Breast cancer is the most frequent cancer among women and is a major cause of cancer-related deaths worldwide. The most prevalent sub-type of breast cancer is hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and accounts for 70% of all breast cancers.
Approximately 90% of breast cancer patients are diagnosed at an early stage of their disease. With current standard of care adjuvant therapy, approximately 30% of HR+ breast cancer patients who are initially diagnosed at early stage experience distant relapse with metastases (spread of the cancer from the primary site to other parts of the body). Thus, there is a critical need to improve the absolute benefit of adjuvant endocrine therapy for HR+ breast cancer patients who are at high risk of disease recurrence.
The study medication abemaciclib is an oral anti-cancer therapy that has shown robust clinical activity in previous Phase 1, Phase 2, and Phase 3 studies of breast cancer patients both as single agent and in combination with standard endocrine (hormone-based) therapy.
The Phase 3 study JPCF, MonarchE, is sponsored by Lilly and will evaluate the potential for abemaciclib to enhance standard adjuvant endocrine therapy compared with standard adjuvant therapy alone in male and female patients with early stage node positive HR+, HER2- breast cancer who are at high risk of disease recurrence. Participants will be randomly assigned to receive either abemaciclib for up to 2 years together with standard of care endocrine therapy (Arm A), or endocrine therapy only (Arm B). Standard endocrine therapy will be taken as prescribed and continue to complete at least 5 years. Participation in MonarchE will continue in the long-term follow up period to complete 10 years.
Approximately 3580 participants from the US, EU, the Middle East, India, Asia-Pacific and South Africa will be selected to take part in MonarchE, with 80 participants from the UK.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0253
Date of REC Opinion
8 Jun 2017
REC opinion
Favourable Opinion