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NCT06086340 Clinical Trial

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.

Breast Cancer Clinical Trial

Official title:
Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06086340
Other study ID # A5481182
Secondary ID Henri IIIHenri 3
Status Completed
Phase
First received
Last updated
Start date September 29, 2023
Est. completion date January 24, 2024

Study information
Verified date May 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States

Recruitment information / eligibility
Status Completed
Enrollment 779
Est. completion date January 24, 2024
Est. primary completion date January 24, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019 - HR+/HER2- molecular subtype at diagnosis - Initiated 1L systemic therapy with palbociclib + AI or AI alone Exclusion Criteria: - Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Palbociclib
Palbociclib with an aromatase inhibitor therapy
• Aromatase Inhibitor
Aromatase Inhibitor Therapy

Locations
Country Name City State
United States Pfizer New York New York New York

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival From 1 February 2015 through 31 December 2019
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