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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: Completed Phase 3 study, sponsored by Pfizer.
NCT01989676 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 707 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by
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 |
What the finished NCT01989676 record still lists
NCT01989676 is an interventional study that assigns participants to a tested intervention. The registered 707 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Paclitaxel is the first listed.
NCT01989676 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989676's enrollment target sits among peer trials
707 505th of 2000 higher than 1,496 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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