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NCT02187744 · ClinicalTrials.gov registry record · Phase 3
A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
NCT02187744: Completed Phase 3 study, sponsored by Pfizer.
NCT02187744 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 226 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187744, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
Study Summary
The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) \>20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%.
Primary Outcome
The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) \>20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.
Interventions
- BIOLOGICAL PF-05280014
- DRUG Taxotere®
- DRUG Paraplatin®
- BIOLOGICAL Trastuzumab-EU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2014-09-23 |
| Est. Completion | 2016-03-09 |
| Phase | Phase 3 |
What the finished NCT02187744 record still lists
NCT02187744 is an interventional study that assigns participants to a tested intervention. The registered 226 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 (71% lower).
The record links to 0 conditions, and to 4 interventions - of which PF-05280014 is the first listed.
NCT02187744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02187744 about?
NCT02187744 is a clinical study titled "A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)". The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with ope...
What is the current status of trial NCT02187744?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2014-09-23. Estimated completion is 2016-03-09.
What interventions are being tested in trial NCT02187744?
The interventions under investigation include: PF-05280014 (BIOLOGICAL), Taxotere® (DRUG), Paraplatin® (DRUG), Trastuzumab-EU (BIOLOGICAL).
Who is sponsoring clinical trial NCT02187744?
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 NCT02187744's enrollment target sits among peer trials
226 1310th of 2000 higher than 690 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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