Clinical trial · Observational
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.
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase Inhibitor | Drug | Aromatase Inhibitor | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Palbociclib + AI
- description
- Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare
- interventionNames
- Drug: Palbociclib
- Drug: Aromatase Inhibitor
- label
- AI alone
- description
- Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy
- interventionNames
- Drug: Aromatase Inhibitor
Primary outcomes (2)
- measure
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBrufsky 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. PMID 40145289