CompletedNot Applicable

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.

United States779 participantsStarted 2023-09-29

Plain-language 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

Who can participate

Age range65 Years

SexALL

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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.

What they're measuring

Overall Survival According to Unadjusted Analysis

Timeframe: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study

Overall Survival According to Stabilized Inverse Probability of Treatment Weighted (sIPTW) Analysis

Timeframe: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study

Trial details

NCT IDNCT06086340

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-01-24

Results submitted2025-01-23

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