N/A
Completed N=779
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.
Source: ClinicalTrials.gov NCT06086340 ↗Enrolled (actual)
779
Serious AEs
—
Results posted
Nov 2025
Primary outcomePrimary: Overall Survival According to Unadjusted Analysis — 24.2; 44.0 Months
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival According to Unadjusted Analysis |
24.2; 44.0 | — |
| PRIMARY Overall Survival According to Stabilized Inverse Probability of Treatment Weighted (sIPTW) Analysis |
25.5; 37.6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06086340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.