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UK Ibrance Patient Program (IPP) Study

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Brigton and Sussex
Brighton, , United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer HR+/HER2- Locally Advanced
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

All patients meeting the following eligibility criteria will be included in the study:

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

All patients meeting the following eligibility criteria will be included in the study:

- 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

NCT03921866
Pfizer
Active, not recruiting
UK Ibrance Patient Program (IPP) Study

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Descriptive Information
Brief TitleUK Ibrance Patient Program (IPP) Study
Official TitleObservational 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)
Brief SummaryWhat 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 (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.

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?

Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationWomen over the age of 18 who entered into the UK IPP
ConditionHR+/HER2- Locally Advanced, Metastatic Breast Cancer
InterventionDrug: Palbociclib
Palbociclib
Study Groups/CohortsNot Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusActive, not recruiting
Estimated Enrollment
 (submitted: April 17, 2019)
250
Original Estimated EnrollmentSame as current
Estimated Study Completion DateDecember 1, 2021
Estimated Primary Completion DateDecember 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

All patients meeting the following eligibility criteria will be included in the study:

  • 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
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited Kingdom
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03921866
Other Study ID NumbersX9001194
ROIS ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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