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Swedish Ibrance Registries Insights (SIRI) (SIRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04654208
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 13, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.

Condition or disease Intervention/treatment
Malignant Neoplasm of Breast Drug: palbociclib

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Palbociclib Treatment Patterns in Swedish Patients With Metastatic Breast Cancer - Swedish Ibrance Registries Insights (SIRI)
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Groups and Cohorts
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Group/Cohort Intervention/treatment
HR+/HER2- locally advanced or MBC in combination with an aromatase inhibitor (AI)
Group Description: patients with at least one filled prescription of palbociclib (ATC (anatomic therapeutic chemical classification system ) code: L01XE33)
 Drug: palbociclib
patients on palbociclib combination treatment
HR+/HER2- locally advanced or MBC cancer in combination with fulvestrant
Group Description: patients with at least one filled prescription of palbociclib ATC (code: L01XE33)
 Drug: palbociclib
patients on palbociclib combination treatment


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients on treatment [ Time Frame: 01 January 2017 until 30 September 2020 ]
    Proportion of patients who have not discontinued treatment will be assessed at various timepoints (Time Frame: treatment start date through end of study [assessed up to 48 months])


Secondary Outcome Measures :
  1. Proportion of patients alive [ Time Frame: 01 January 2017 until 30 September 2020 ]
    Proportion of patients alive on palbociclib combination treatment at different points in time (Time Frame: treatment start date through end of study [assessed up to 48 months])

  2. Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment [ Time Frame: 01 January 2017 until 30 September 2020 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include all adult (age ≥18 years) patients (male and female) with at least one filled prescription of palbociclib (ATC code: L01XE33) registered in the Swedish Prescribed Drug Register between January 1st, 2017 and June 30th 2020.
Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33)
  2. Age ≥18 years at index date

Exclusion Criteria:

There are no exclusion criteria

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): NCT04654208


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sweden
Pfizer AB Recruiting
Sollentuna, Sweden
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04654208    
Other Study ID Numbers: A5481158
SIRI ( Other Identifier: Alias Study Number )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 13, 2022
Last Verified: December 2022
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.
Keywords provided by Pfizer:
metastatic breast cancer (MBC)
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
 Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action