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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 226 participants.
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%.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02187744
The ClinicalTrials.gov registry entry for NCT02187744 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 226 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 4 interventions - of which PF-05280014 is the first listed.
NCT02187744 reports 0 study locations.
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.
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