Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03921866
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2019-04-17
Brief Title:
UK Ibrance Patient Program IPP Study
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Observational Cohort Study of Patients With Hormone Receptor-positive Metastatic Breast Cancer Treated With Palbociclib IbranceRegistered as Part of the United Kingdom Ibrance Registered Patient Program IPP the Real Outcomes Ibrance Registered Study ROIS
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROIS
Brief Summary:
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 hormone receptor-positive human epidermal growth factor 2-negative metastatic breast cancer treated as part of the IPP
Detailed Description:
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 CDK46 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 HRHER2- 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 NICESMC appraisal period the Ibrance Patient Program IPP was initiated and run by Pfizer between April 2017 until a positive NICESMC 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
Research question
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 HRHER2- MBC treated as part of the IPP
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
Research question
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 HRHER2- MBC treated as part of the IPP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ROIS | OTHER | Alias Study Number | None |