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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 521 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01942135
The ClinicalTrials.gov registry entry for NCT01942135 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 521 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01942135 reports 0 study locations.
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.
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