Study Results
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View full resultsBasic Information
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COMPLETED
652 participants
OBSERVATIONAL
2017-06-12
2021-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Breast Cancer Patients
HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.
* Agrees to participate in the study and complete the eCRFs within the data collection period.
* Female
* ≥18 years old.
* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
* Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).
* No prior or current enrolment in an interventional clinical trial for ABC/MBC.
* Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).
* Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).
* Inoperable or recurrent breast cancer (Japan only)
Exclusion Criteria
* Participated in observational research for ABC/MBC in the last 3 months
* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).
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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Pfizer, Inc.
New York, New York, United States
Countries
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References
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Mycock K, Zhan L, Hart K, Taylor-Stokes G, Milligan G, Atkinson C, Mitra D. Real-world treatment patterns and clinical outcomes in patients receiving palbociclib combinations for HR+/HER2- advanced/metastatic breast cancer in Japan: Results from the IRIS study. Cancer Treat Res Commun. 2022;32:100573. doi: 10.1016/j.ctarc.2022.100573. Epub 2022 May 6.
Mycock K, Zhan L, Taylor-Stokes G, Milligan G, Mitra D. Real-World Palbociclib Use in HR+/HER2- Advanced Breast Cancer in Canada: The IRIS Study. Curr Oncol. 2021 Jan 24;28(1):678-688. doi: 10.3390/curroncol28010066.
Waller J, Mitra D, Mycock K, Taylor-Stokes G, Milligan G, Zhan L, Iyer S. Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study. J Glob Oncol. 2019 May;5:JGO1800239. doi: 10.1200/JGO.18.00239.
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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IRIS
Identifier Type: OTHER
Identifier Source: secondary_id
A5481090
Identifier Type: -
Identifier Source: org_study_id
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