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NCT01942135 · ClinicalTrials.gov registry record · Phase 3
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 521
- Enrollment target
NCT01942135: Completed Phase 3 study, sponsored by Pfizer.
NCT01942135 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 521 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01942135, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 521 participants
- Enrollment target
Study Summary
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).
Primary Outcome
PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were cen
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG Palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 521 participants |
| Start Date | 2013-09-26 |
| Est. Completion | 2022-09-28 |
| Phase | Phase 3 |
What the finished NCT01942135 record still lists
NCT01942135 is an interventional study that assigns participants to a tested intervention. The registered 521 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 (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01942135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01942135 about?
NCT01942135 is a clinical study titled "Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)". The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cance...
What is the current status of trial NCT01942135?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 521 participants. The study started on 2013-09-26. Estimated completion is 2022-09-28.
What interventions are being tested in trial NCT01942135?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG).
Who is sponsoring clinical trial NCT01942135?
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 NCT01942135's enrollment target sits among peer trials
521 717th of 2000 higher than 1,284 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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