Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
NCT ID: NCT05361655
Last Updated: 2024-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
2888 participants
OBSERVATIONAL
2021-09-01
2021-09-01
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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Palbociclib + an aromatase inhibitor
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.
Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
Aromatase inhibitor
Adult metastatic breast cancer patients who initiated an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.
Aromatase inhibitor
Aromatase inhibitor therapy
Interventions
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Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
Aromatase inhibitor
Aromatase inhibitor therapy
Eligibility Criteria
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Inclusion Criteria
* Received palbociclib + AI or AI as first-line therapy
Exclusion Criteria
* First structured activity greater than 90 days after MBC diagnostic date
* Treatment with a CDK4/6 inhibitor as part of a clinical trial
18 Years
ALL
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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10017
New York, New York, United States
Countries
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References
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Layman RM, Liu X, Li B, McRoy L, Brufsky A. Real-world palbociclib dose modifications and clinical outcomes in patients with HR+/HER2- metastatic breast cancer: A Flatiron Health database analysis. Breast. 2025 Jun;81:104448. doi: 10.1016/j.breast.2025.104448. Epub 2025 Mar 17.
Brufsky A, Liu X, Li B, McRoy L, Chen C, Makari D, Layman RM, Rugo HS. Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: real-world effectiveness. Oncologist. 2024 Dec 6;29(12):1032-1043. doi: 10.1093/oncolo/oyae273.
Rugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Tomlin-Harris T, Brufsky A. Prolonging the lives of African-Americans with metastatic breast cancer by adding palbociclib to an aromatase inhibitor in routine clinical practice: a plain language summary of a real-world database study. Future Oncol. 2024;20(19):1299-1307. doi: 10.2217/fon-2023-1079. Epub 2024 Mar 22.
Rugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Brufsky A. Real-World Effectiveness of Palbociclib Plus Aromatase Inhibitors in African American Patients With Metastatic Breast Cancer. Oncologist. 2023 Oct 3;28(10):866-874. doi: 10.1093/oncolo/oyad209.
Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Prolonging the life of people with metastatic breast cancer in routine clinical practice by adding palbociclib to an aromatase inhibitor from a real-world database analysis: a plain language summary. Future Oncol. 2023 Mar;19(7):489-498. doi: 10.2217/fon-2022-1192. Epub 2023 Mar 9.
Rugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ Breast Cancer. 2022 Oct 11;8(1):114. doi: 10.1038/s41523-022-00479-x.
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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A5481151
Identifier Type: -
Identifier Source: org_study_id
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