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.
- Registration Number
- NCT06086340
- Lead Sponsor
- Pfizer
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 779
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Palbociclib + AI Aromatase Inhibitor Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare AI alone Aromatase Inhibitor Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy Palbociclib + AI Palbociclib Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare
- Primary Outcome Measures
Name Time Method Overall Survival From 1 February 2015 through 31 December 2019
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer New York
🇺🇸New York, New York, United States