REPOWER
Research type
Research Study
Full title
REPOWER: "Real-world Evaluation of Patient Outcomes and Experiences with Ribociclib Early Adopters: A Hybrid Study with Prospective Patient-reported Outcomes and Retrospective Clinical Chart Review"
IRAS ID
362912
Contact name
Alistair Ring
Contact email
Sponsor organisation
Novartis Pharma AG
Duration of Study in the UK
4 years, 5 months, 1 days
Research summary
This study is a real-world evaluation of patient outcomes and experiences with ribociclib (Kisqali) early adopters. It is a hybrid study integrating the collection of real-world clinical outcomes using data collected from medical records, as well as the collection of patient self-reported qualitative and quantitative experiences on symptoms, impacts and overall experience with treatment (PROs). This will enable understanding of clinical benefits, past experiences and side effects associated with ribociclib+ endocrine therapy (ET) in routine clinical practice, supporting patient-centred value assessment and informing optimal use in the broader breast cancer population. Additionally, the study will collect data on PROs and side effects for abemaciclib (Verzenios)+ ET.
This study is being sponsored by Novartis Pharma AG and will be conducted across several countries. The study will enrol about 2900 patients with HR+/HER2- stage II and III early breast cancer. (about 2650 treated with ribociclib plus ET and about 250 treated with abemaciclib plus ET).
Participants treated with ribociclib will be in the study for a maximum of 54 months and those treated with abemaciclib will be in the study for a maximum of 42 months.REC name
South West - Frenchay Research Ethics Committee
REC reference
25/SW/0117
Date of REC Opinion
20 Oct 2025
REC opinion
Further Information Favourable Opinion