Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
NCT ID: NCT06086340
Last Updated: 2025-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
779 participants
OBSERVATIONAL
2023-09-29
2024-01-24
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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Palbociclib + AI
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare
Palbociclib
Palbociclib with an aromatase inhibitor therapy
Aromatase Inhibitor
Aromatase Inhibitor Therapy
AI alone
Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy
Aromatase Inhibitor
Aromatase Inhibitor Therapy
Interventions
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Palbociclib
Palbociclib with an aromatase inhibitor therapy
Aromatase Inhibitor
Aromatase Inhibitor Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HR+/HER2- molecular subtype at diagnosis
* Initiated 1L systemic therapy with palbociclib + AI or AI alone
Exclusion Criteria
65 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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Pfizer New York
New York, New York, United States
Countries
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References
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Brufsky AM, Sandin R, Stergiopoulos S, Chen C, Karanth S, Li B, Esterberg E, Makari D, Candrilli SD, Goyal RK, Rugo HS. Overall Survival With Palbociclib and Aromatase Inhibitor Versus Aromatase Inhibitor Alone in Older Patients With HR+/HER2- Metastatic Breast Cancer. Cancer Med. 2025 Apr;14(7):e70719. doi: 10.1002/cam4.70719.
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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Henri 3
Identifier Type: OTHER
Identifier Source: secondary_id
A5481182
Identifier Type: -
Identifier Source: org_study_id
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