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NCT01740427 · ClinicalTrials.gov registry record · Phase 3
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 666
- Enrollment target
NCT01740427: Completed Phase 3 study, sponsored by Pfizer.
NCT01740427 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 666 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01740427, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 666 participants
- Enrollment target
Study Summary
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.
Primary Outcome
PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a
Interventions
- DRUG Placebo
- DRUG Letrozole
- DRUG PD-0332991
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 666 participants |
| Start Date | 2013-02-22 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 3 |
What the finished NCT01740427 record still lists
NCT01740427 is an interventional study that assigns participants to a tested intervention. The registered 666 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01740427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01740427 about?
NCT01740427 is a clinical study titled "A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)". The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their ...
What is the current status of trial NCT01740427?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 666 participants. The study started on 2013-02-22. Estimated completion is 2023-11-09.
What interventions are being tested in trial NCT01740427?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG), PD-0332991 (DRUG).
Who is sponsoring clinical trial NCT01740427?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01740427's enrollment target sits among peer trials
666 551st of 2000 higher than 1,449 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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