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NCT04176354 · ClinicalTrials.gov registry record
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 813
- Enrollment target
NCT04176354: Completed study, sponsored by Pfizer.
NCT04176354 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 813 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04176354 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 813 participants
- Enrollment target
Study 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.
Primary Outcome
rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visi
Interventions
- DRUG Letrozole
- DRUG Palbociclib + an aromatase inhibitor
- DRUG Palbociclib + Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2019-01-25 |
| Est. Completion | 2019-09-27 |
What the finished NCT04176354 record still lists
NCT04176354 is an observational study that tracks outcomes without assigning an intervention. The registered 813 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Letrozole is the first listed.
NCT04176354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04176354 about?
NCT04176354 is a clinical study titled "Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy". 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.
What is the current status of trial NCT04176354?
This trial is currently completed. The enrollment target is 813 participants. The study started on 2019-01-25. Estimated completion is 2019-09-27.
What interventions are being tested in trial NCT04176354?
The interventions under investigation include: Letrozole (DRUG), Palbociclib + an aromatase inhibitor (DRUG), Palbociclib + Letrozole (DRUG).
Who is sponsoring clinical trial NCT04176354?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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