monarcHER: Phase 2, 3-Arm, Study in Women with Advanced Breast Cancer
Research type
Research Study
Full title
A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib plus Trastuzumab with or without Fulvestrant to the Standard-of-Care Chemotherapy of Physician’s Choice plus Trastuzumab in Women with HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
IRAS ID
198560
Contact name
Daniel Brock
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-003400-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Breast cancer is one of the most common cancers in women. At early stage, breast cancer is treatable, but when cancer spreads to other areas (metastasises), survival rate is generally only 2 to 3 years (Cardoso et al. 2012).
Overexpression of human epidermal growth factor receptor 2 (HER2) occurs in the cells of 20% to 25% of breast cancers, approximately half of these tumours also express hormone receptors (HR) (Konecny et al. 2003). Patients in this population are typically treated with HER2-targeted endocrine therapies, however resistance to these therapies is a common clinical problem and HER2+ and HR+ metastatic breast cancer remains an incurable disease.
Cyclin-dependent kinases (CDK) are a family of proteins that regulate processes and growth in all cells. CDK 4 is a member of this family that acts to drive cancer cell growth. The investigational study drug, Abemaciclib, is a potent inhibitor (substance that blocks a biological pathway) that selectively binds to CDK 4 and 6 proteins therefore enhancing the clinical response to endocrine therapy and overcoming the mechanism of resistance.
The monarcHER study is evaluating the effectiveness and tolerability of Abemaciclib (study drug) plus Trastuzumab and Fulvestrant (endocrine therapy) and Abemaciclib and only Trastuzumab compared to the standard-of-care treatment and Trastuzumab in patients with advanced breast cancer.
To be eligible to participate in this study patients have to have HR+ and HER2+ advanced breast cancer. The study duration will be approximately 4 years and patients will continue on the study for as long as they are benefiting from the study treatment.
Study assessments will include: Physical examinations, questionnaire completion, blood tests, ECG and radiological scans (CT, MRI, X-ray and bone scan).
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/0595
Date of REC Opinion
16 May 2016
REC opinion
Further Information Favourable Opinion