UK Ibrance Patient Program (IPP) Study (ROIS)
|ClinicalTrials.gov Identifier: NCT03921866|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2019
Last Update Posted : December 21, 2020
|Condition or disease||Intervention/treatment|
|HR+/HER2- Locally Advanced, Metastatic Breast Cancer||Drug: Palbociclib|
Hormone receptor positive (HR+) breast cancer (BC) represents the largest therapeutic subtype of the disease, accounting for 60 to 65% of all malignant neoplasms of the breast. Palbociclib (Ibrance®) is a small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) which in clinical trial settings has been shown to increase progression-free survival (PFS) for patients with HR+, human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib first received a European Union (EU) marketing authorisation in September 2016, to be commercialised as Ibrance® by Pfizer. Palbociclib was recommended for use with an aromatase inhibitor in patients with HR+/HER2- locally advanced and MBC in the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE) in November 2017 and by the Scottish Medicines Consortium (SMC) in December 2017. In order to provide access to palbociclib in the United Kingdom (UK) during the NICE/SMC appraisal period, the Ibrance® Patient Program (IPP) was initiated and run by Pfizer between April 2017 until a positive NICE/SMC appraisal in November 2017 (for England and Wales) or December 2017 (for Scotland).
Pfizer are interested in the opportunity to collect data from patients who received palbociclib as part of the UK IPP, to better understand patients' characteristics in a routine care setting, treatment persistence and dose management, clinical outcomes, and healthcare resource utilisation. This study will provide real-world evidence on patients' clinical progression and experience of treatment with palbociclib in routine clinical settings in a UK context.
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with HR+/HER2- MBC treated as part of the IPP?
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Observational Cohort Study of Patients With Hormone Receptor-positive Metastatic Breast Cancer Treated With Palbociclib (Ibrance(Registered)) as Part of the United Kingdom Ibrance (Registered) Patient Program (IPP); the Real Outcomes Ibrance (Registered) Study (ROIS)|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
- Drug: Palbociclib
- Clinical characteristics [ Time Frame: 36 months ]To describe patient demographic and clinical characteristics at initiation of palbociclib.
- To describe treatment pattern (as per licence/IPP requirement); [ Time Frame: 36 month ]proportion of patients with dose modification and who switch treatment 1, 2 and 3 years after palbociclib initiation
- Median time [ Time Frame: 36 Months ]Median time to dose modification Treatment discontinuation ('drug survival').
- Progression [ Time Frame: 36 months ]For patients who progress, to describe the 1st/2nd /3rd line of treatment after progression.
- Survival [ Time Frame: 36 months ]To describe overall survival, Progression-free survival Median progression free survival
- Response [ Time Frame: 36 months ]Complete response, Partial response; including the
- Duration of response [ Time Frame: 36 months ]Duration of response
- AEs [ Time Frame: 36 months ]To describe the occurrence of neutropenia To describe the occurrence of gastro-intestinal toxicity
- Healthcare uitilisation [ Time Frame: 36 months ]healthcare resource utilisation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921866
|Brigton and Sussex|
|Brighton, United Kingdom|
|Glasgow, United Kingdom|
|Liverpool, United Kingdom|
|Guys and St Thomas'|
|London, United Kingdom|
|Maidstone, United Kingdom|
|Manchester, United Kingdom|
|Newcastle, United Kingdom|
|Truro, United Kingdom|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|