Ribociclib Non-Interventional Study
Research type
Research Study
Full title
Prospective observational study to describe effectiveness and socio-economic impact of ribociclib in clinical practice in the United Kingdom.
IRAS ID
244995
Contact name
Heena Tosar
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Clinicaltrials.gov Identifier
NIHR CRN Porfolio, CANC 37654
Duration of Study in the UK
4 years, 1 months, 24 days
Research summary
The main purpose of this prospective, non-interventional, observational study is to describe the effectiveness of ribociclib for the treatment of patients with locally advanced or metastatic breast cancer (BC) in the real life setting across clinical practices in the United Kingdom (UK).
Approximately 150 patients with locally advanced or metastatic breast cancer, treated with ribociclib in combination with an aromatase inhibitor (AI) (another treatment for advanced breast cancer), in clinical practice will be enrolled in this study across approximately 15 hospital sites in the UK.
The results from this study will provide a relevant set of information to inform future management of patients with advanced breast cancer in clinical practice.
This observational study does not impose any tests or assessments outside of the patients' routine care. Patients will be treated according to local prescribing information for ribociclib (in combination with an aromatase inhibitor) and they will be treated according to routine medical practice in terms of visit frequency and types of assessments performed, at the discretion of the investigator. Only this data will be collected as part of the study.
Patients will be asked to complete four questionnaires about their general health status and how the disease and treatment affects their daily life. For each eligible participant, written informed consent must be obtained prior to any study related activities.
The expected duration of this study is approximately 3 years.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0340
Date of REC Opinion
15 May 2018
REC opinion
Further Information Favourable Opinion