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UK Ibrance Patient Program (IPP) Study (ROIS)

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ClinicalTrials.gov Identifier: NCT03921866
Recruitment Status : Active, not recruiting
First Posted : April 19, 2019
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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?

Condition or disease Intervention/treatment
HR+/HER2- Locally Advanced, Metastatic Breast Cancer Drug: Palbociclib

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 Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Groups and Cohorts
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Intervention Details:
  • Drug: Palbociclib
    Palbociclib

Outcome Measures
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Primary Outcome Measures :
  1. Clinical characteristics [ Time Frame: 36 months ]
    To describe patient demographic and clinical characteristics at initiation of palbociclib.


Secondary Outcome Measures :
  1. 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

  2. Median time [ Time Frame: 36 Months ]
    Median time to dose modification Treatment discontinuation ('drug survival').

  3. Progression [ Time Frame: 36 months ]
    For patients who progress, to describe the 1st/2nd /3rd line of treatment after progression.

  4. Survival [ Time Frame: 36 months ]
    To describe overall survival, Progression-free survival Median progression free survival

  5. Response [ Time Frame: 36 months ]
    Complete response, Partial response; including the

  6. Duration of response [ Time Frame: 36 months ]
    Duration of response

  7. AEs [ Time Frame: 36 months ]
    To describe the occurrence of neutropenia To describe the occurrence of gastro-intestinal toxicity

  8. Healthcare uitilisation [ Time Frame: 36 months ]
    healthcare resource utilisation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women over the age of 18 who entered into the UK IPP
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921866


Locations
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United Kingdom
Brigton and Sussex
Brighton, United Kingdom
Beatson
Glasgow, United Kingdom
Liverpool
Liverpool, United Kingdom
Guys and St Thomas'
London, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom
Christie
Manchester, United Kingdom
Newcastle
Newcastle, United Kingdom
Truro
Truro, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03921866    
Other Study ID Numbers: X9001194
ROIS ( Other Identifier: Alias Study Number )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: August 2020
Individual Participant Data (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/data_requests.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action