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NCT05361655 · ClinicalTrials.gov registry record
Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 2,888
- Enrollment target
NCT05361655: Completed study, sponsored by Pfizer.
NCT05361655 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 2,888 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05361655 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 2,888 participants
- Enrollment target
Study 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.
Primary Outcome
OS was defined as the time from the index date (start of palbociclib + AI or AI alone) to death. Participants who did not die, were censored at the end of study date (30-Sep-2020). Kaplan-Meier method adjusted by stabilized inverse probability of treatment weighting (sIPTW) was used.
Interventions
- DRUG Aromatase inhibitor
- DRUG Palbociclib + an aromatase inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,888 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2021-09-01 |
What the finished NCT05361655 record still lists
NCT05361655 is an observational study that tracks outcomes without assigning an intervention. Its 2,888 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Aromatase inhibitor is the first listed.
NCT05361655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05361655 about?
NCT05361655 is a clinical study titled "Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor". 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 hor...
What is the current status of trial NCT05361655?
This trial is currently completed. The enrollment target is 2,888 participants. The study started on 2021-09-01. Estimated completion is 2021-09-01.
What interventions are being tested in trial NCT05361655?
The interventions under investigation include: Aromatase inhibitor (DRUG), Palbociclib + an aromatase inhibitor (DRUG).
Who is sponsoring clinical trial NCT05361655?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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