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NCT05012644 · ClinicalTrials.gov registry record
Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 197
- Enrollment target
NCT05012644: Completed study, sponsored by Pfizer.
NCT05012644 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 197 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05012644 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 197 participants
- Enrollment target
Study Summary
This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on or after 01 January 2010 to on or before 30 June 2020. Data will be obtained from structured data fields within an electronic health record (EHR) database and will be supplemented by additional unstructured data collected through a targeted chart review.
Primary Outcome
rwTR of complete response (CR) or partial response (PR) based on response assessments captured with chart review during first line therapy. Real-world response rate (rwRR) was estimated using nIPTW method to adjust for the potential imbalance between the 2 treatment cohorts. CR was documented as 'a complete response' to therapy, indication patient is in 'remission', 'all lesions' have disappeared, or 'no evidence of disease'. PR was documented as partial reduction in size of visible disease in s
Interventions
- DRUG Aromatase inhibitor
- DRUG Palbociclib + aromatase inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2021-12-09 |
What the finished NCT05012644 record still lists
NCT05012644 is an observational study that tracks outcomes without assigning an intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Aromatase inhibitor is the first listed.
NCT05012644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05012644 about?
NCT05012644 is a clinical study titled "Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone". This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on or after 01 January 2010 to on or before 30 June 2020. Data will be obt...
What is the current status of trial NCT05012644?
This trial is currently completed. The enrollment target is 197 participants. The study started on 2021-07-16. Estimated completion is 2021-12-09.
What interventions are being tested in trial NCT05012644?
The interventions under investigation include: Aromatase inhibitor (DRUG), Palbociclib + aromatase inhibitor (DRUG).
Who is sponsoring clinical trial NCT05012644?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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