Study Results
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View full resultsBasic Information
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COMPLETED
191 participants
OBSERVATIONAL
2019-03-01
2021-03-04
Brief Summary
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Detailed Description
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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 HR+/HER2- MBC treated as part of the IPP?
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Palbociclib
Palbociclib
Eligibility Criteria
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Inclusion Criteria
* Patients enrolled into the IPP at one of the selected hospitals (see Annex 1 for IPP enrolment letter).
* Patients who received ≥1 dose of palbociclib as part of the IPP at one of the selected sites.
* For sites where data collection is performed by pH Associates, written informed consent will be required from living patients to access their medical records.
* Patient aged ≥18 years old at enrollment into the IPP
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Brighton Sussex Cancer Centre
Brighton, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Guys and St Thomas' NHS Trust
London, , United Kingdom
Maidstone Hospital
Maidstone, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Clatterbridge
Metropolitan Borough of Wirral, , United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Palmieri C, Musson A, Harper-Wynne C, Wheatley D, Bertelli G, Macpherson IR, Nathan M, McDowall E, Bhojwani A, Verrill M, Eva J, Doody C, Chowdhury R. A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance(R) Patient Program. Br J Cancer. 2023 Sep;129(5):852-860. doi: 10.1038/s41416-023-02352-5. Epub 2023 Jul 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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ROIS
Identifier Type: OTHER
Identifier Source: secondary_id
X9001194
Identifier Type: -
Identifier Source: org_study_id
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