Clinical trial · Observational
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
Palbociclib Treatment Patterns and Outcomes in HR+/HER2- MBC: Flatiron Database Analysis
- 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)
Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies. The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy. The study will also evaluate how long patients take the different CDK 4/6 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later. Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study: * HR+/HER2- MBC * First treatment with Palbociclib, hormonal therapy, or other CDK4/6 inhibitors after MBC diagnosis The study will use data without personal identity, which were obtained from medical records in routine clinical practice.
Conditions
Conditions (2)
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 |
| Malignant Neoplasm of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Aromatase inhibitor | Drug | Aromatase Inhibitor | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (4)
- label
- Palbociclib + aromatase inhibitor (AI)
- description
- Oral palbociclib + AI combination treatment regimen as decided by physician
- interventionNames
- Drug: Palbociclib
- Drug: Aromatase inhibitor
- label
- Aromatase inhibitor (AI)
- description
- Oral AI treatment regimen as decided by physician
- interventionNames
- Drug: Aromatase inhibitor
- label
- Abemaciclib plus aromatase inhibitor (AI)
- description
- Oral abemaciclib plus AI treatment regimen as decided by physician
- interventionNames
- Drug: Palbociclib
- Drug: Aromatase inhibitor
- Drug: Abemaciclib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patients are eligible for the study if they were 18 years of age or older at MBC diagnosis, had HR+/HER2- confirmed and initiated first line therapy (CDK4/6i, ET, CT, or other) in the metastatic setting during the period from February 2015 through June 2022 or data cutoff.
References
Publications (5)
- DERIVEDRugo HS, Layman RM, Lynce F, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Curigliano G, Brufsky A. Comparison of survival outcomes for people with HR+/HER2- metastatic breast cancer who received palbociclib, ribociclib, or abemaciclib with an aromatase inhibitor: a plain language summary. Future Oncol. 2026 Jun;22(14):1625-1635. doi: 10.1080/14796694.2026.2674970. Epub 2026 Jun 21. PMID 42324670
- DERIVEDBrufsky A, Layman RM, Liu X, Li B, McRoy L, Cohen A, Estevez M, Cottu P, Thill M, Curigliano G, Rugo HS. Real-world treatment durations, subsequent treatments, and switching of CDK4/6 inhibitors among patients with HR+/HER2- metastatic breast cancer. Oncologist. 2026 May 8;31(6):oyag182. doi: 10.1093/oncolo/oyag182. PMID 42095602
- DERIVEDRugo HS, Brufsky A, Layman RM, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Lynce F, Cottu P, Thill M, Curigliano G. Real-world progression-free survival 2 (PFS2) and tumor response of CDK4/6 inhibitors plus an aromatase inhibitor in patients with HR+/HER2- metastatic breast cancer in US routine clinical practice. Breast. 2026 Jun;87:104780. doi: 10.1016/j.breast.2026.104780. Epub 2026 Mar 30. PMID 41950642
- DERIVEDBrufsky A, Layman RM, Liu X, Li B, McRoy L, Cohen AB, Estevez M, Cottu P, Curigliano G, Rugo HS. Real-world effectiveness of palbociclib in combination with an aromatase inhibitor in HR+/HER2- bone-only metastatic breast cancer. Breast. 2026 Apr;86:104744. doi: 10.1016/j.breast.2026.104744. Epub 2026 Feb 24. PMID 41830752
- DERIVEDLynce F, Liu X, Li B, McRoy L, Chen C, Liu R, Rugo HS. Real-world effectiveness of palbociclib plus an aromatase inhibitor in HR+/HER2- MBC patients living in disadvantaged neighborhoods. NPJ Breast Cancer. 2025 Jul 21;11(1):75. doi: 10.1038/s41523-025-00786-z. PMID 40691446