N/A
Completed N=813
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy
Source: ClinicalTrials.gov NCT04176354 ↗Enrolled (actual)
813
Serious AEs
—
Results posted
Aug 2024
Primary outcomePrimary: Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method — 20.0 Months
Summary
A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method |
20.0 | — |
| SECONDARY Overall Survival (OS): Using Kaplan-Meier Method |
NA | — |
| SECONDARY Number of Participants With Real World Tumour Response (rwTR) |
67; 355; 166; 98; 17; 110 | — |
| SECONDARY Response Rate |
0.519 | — |
| SECONDARY Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method |
16.3 | — |
| SECONDARY Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method |
24.6 | — |
| SECONDARY Time to First Use of Chemotherapy: Using Kaplan-Meier Method |
36.6 | — |
Eligibility Criteria
Inclusion Criteria
- Female sex
- At least 18 years old at MBC diagnosis
- Diagnosis of MBC at any point in patient history
- ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC
- Confirmation of metastatic disease
- At least 2 document clinical visits
- Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents
- HR+/HER2-
- HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
- HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
- Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.
Exclusion Criteria
- Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), 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 (NCT04176354). 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.