N/A
Completed N=2,888
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
Source: ClinicalTrials.gov NCT05361655 ↗Enrolled (actual)
2,888
Serious AEs
—
Results posted
Jun 2024
Primary outcomePrimary: Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer — 49.1; 43.2 Months — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer |
49.1; 43.2 | <0.0001 sig |
| SECONDARY Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer |
19.3; 13.9 | <0.0001 sig |
| SECONDARY Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer |
163; 86; 569; 300; 350; 273 | — |
| SECONDARY Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer |
57.98; 39.04 | <0.0001 sig |
| SECONDARY Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only |
48; 1110; 144; 22 | — |
| SECONDARY Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only |
85; 95; 112 | — |
| SECONDARY Duration of Treatment |
12.3; 5.5 | <0.0001 sig |
| SECONDARY Time to Next Line of Treatment |
18.4; 8.3 | <0.0001 sig |
| SECONDARY Time to Subsequent Chemotherapy |
37.4; 29.2 | <0.0001 sig |
| SECONDARY Real-World Progression Free Survival 2 (rwPFS2) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer |
32.6; 20.7 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05361655). 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.