Clinical trial · Observational
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as 1st Line Therapy in Metastatic Breast Cancer
NCT05361655CI-TRIAL-00077798completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase inhibitor | Drug | Aromatase Inhibitor | ALIAS |
| Palbociclib + an aromatase inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Palbociclib + an aromatase inhibitor
- description
- Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.
- interventionNames
- Drug: Palbociclib + an aromatase inhibitor
- label
- Aromatase inhibitor
- description
- Adult metastatic breast cancer patients who initiated an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.
- interventionNames
- Drug: Aromatase inhibitor
Primary outcomes (1)
- measure
- Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer
- timeFrame
- From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed HR+/HER2- status after MBC diagnosis. * Received palbociclib + AI or AI as first-line therapy Exclusion Criteria: * Evidence of prior treatment with other CDK4/6I, AI, tamoxifen, raloxifene, toremifene, or Fulvestrant for MBC * First structured activity greater than 90 days after MBC diagnostic date * Treatment with a CDK4/6 inhibitor as part of a clinical trial
References
Publications (7)
- DERIVEDRugo HS, Liu X, Li B, McRoy L, Chen C, Makari D, Layman RM, Brufsky A. Treatment outcomes with palbociclib plus an aromatase inhibitor in patients with metastatic breast cancer who also have cardiovascular diseases: a plain language summary. Future Oncol. 2026 Jun;22(14):1613-1623. doi: 10.1080/14796694.2026.2672130. Epub 2026 Jun 21. PMID 42324685
- DERIVEDLayman RM, Liu X, Li B, McRoy L, Brufsky A. Real-world palbociclib dose modifications and clinical outcomes in patients with HR+/HER2- metastatic breast cancer: A Flatiron Health database analysis. Breast. 2025 Jun;81:104448. doi: 10.1016/j.breast.2025.104448. Epub 2025 Mar 17. PMID 40138984
- DERIVEDBrufsky A, Liu X, Li B, McRoy L, Chen C, Makari D, Layman RM, Rugo HS. Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: real-world effectiveness. Oncologist. 2024 Dec 6;29(12):1032-1043. doi: 10.1093/oncolo/oyae273. PMID 39418346
- DERIVEDRugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Tomlin-Harris T, Brufsky A. Prolonging the lives of African-Americans with metastatic breast cancer by adding palbociclib to an aromatase inhibitor in routine clinical practice: a plain language summary of a real-world database study. Future Oncol. 2024;20(19):1299-1307. doi: 10.2217/fon-2023-1079. Epub 2024 Mar 22. PMID 38517416
- DERIVEDRugo HS, Liu X, Li B, McRoy L, Chen C, Layman RM, Brufsky A. Real-World Effectiveness of Palbociclib Plus Aromatase Inhibitors in African American Patients With Metastatic Breast Cancer. Oncologist. 2023 Oct 3;28(10):866-874. doi: 10.1093/oncolo/oyad209. PMID 37487056
- DERIVEDRugo HS, Brufsky A, Liu X, Li B, McRoy L, Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, Finn RS, DeMichele A. Prolonging the life of people with metastatic breast cancer in routine clinical practice by adding palbociclib to an aromatase inhibitor from a real-world database analysis: a plain language summary. Future Oncol. 2023 Mar;19(7):489-498. doi: 10.2217/fon-2022-1192. Epub 2023 Mar 9.