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NCT04654208 Clinical Trial

Swedish Ibrance Registries Insights (SIRI)

Malignant Neoplasm of Breast Clinical Trial

— SIRI  

Official title:
Palbociclib Treatment Patterns in Swedish Patients With Metastatic Breast Cancer - Swedish Ibrance Registries Insights (SIRI)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04654208
Other study ID # A5481158
Secondary ID SIRI
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2020
Est. completion date December 31, 2022

Study information
Verified date December 2022
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• palbociclib
patients on palbociclib combination treatment

Locations
Country Name City State
Sweden Pfizer AB Sollentuna

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients on treatment 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]) 01 January 2017 until 30 September 2020
Secondary Proportion of patients alive 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]) 01 January 2017 until 30 September 2020
Secondary Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment 01 January 2017 until 30 September 2020
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