The Real Outcomes Ibrance Study (ROIS)
Research type
Research Study
Full title
Observational cohort study of patients with hormone receptor-positive metastatic breast cancer treated with palbociclib (Ibrance®) as part of the United Kingdom Ibrance® Patient Program (IPP); the Real Outcomes Ibrance® Study (ROIS)
IRAS ID
252363
Contact name
Carlo Palmieri
Contact email
Sponsor organisation
Pfizer Ltd
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 6 months, 28 days
Research summary
This study has been designed to address the following research question:
What are the treatment patterns, patients’ characteristics, clinical outcomes and healthcare resource use associated with palbociclib treatment in the 3 years following initiation in UK patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer treated in the NHS as part of the the Ibrance® Patient Program (IPP).This is a multi-centre, observational cohort study. This study will be conducted in 8-9 NHS Trusts across different regions within the UK.
The study is based on both retrospective and prospective collection of data from patients’ medical records covering the 3 year period following palbociclib initiation. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required.
The population for this study is adult patients diagnosed with locally advanced or metastatic breast cancer who received treatment with palbociclib as part of the IPP. Across the entire UK, 846 women received palbociclib as part of the IPP. The study is expected to recruit approximately 250 patients who received palbociclib as part of the IPP within the selected sites.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1859
Date of REC Opinion
19 Oct 2018
REC opinion
Favourable Opinion