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NCT01989676 · ClinicalTrials.gov registry record · Phase 3
A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 707
- Enrollment target
NCT01989676 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 707 participants.
The verdict
NCT01989676, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 707 participants
- Enrollment target
Study Summary
The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.
Interventions
- DRUG Paclitaxel
- BIOLOGICAL PF-05280014
- BIOLOGICAL Herceptin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 707 participants |
| Start Date | 2014-02-24 |
| Est. Completion | 2020-06-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01989676
The ClinicalTrials.gov registry entry for NCT01989676 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 707 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 Paclitaxel is the first listed.
NCT01989676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01989676 about?
NCT01989676 is a clinical study titled "A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)". The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line...
What is the current status of trial NCT01989676?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 707 participants. The study started on 2014-02-24. Estimated completion is 2020-06-27.
What interventions are being tested in trial NCT01989676?
The interventions under investigation include: Paclitaxel (DRUG), PF-05280014 (BIOLOGICAL), Herceptin® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01989676?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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