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Clinical trial

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)

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Last updated:24th Feb 2014
Identifier: NCT01989676
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.



Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind Study Of Pf-05280014 Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel For The First-line Treatment Of Patients With Her2-positive Metastatic Breast Cancer
Estimated Enrollment: 690
Actual Study Start Date: February 24, 2014
Estimated Study Completion Date: February 26, 2019
Primary Completion Date: August 24, 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
PF-05280014
- Active Comparator: Herceptin®

Category Value
Date last updated at source 2017-07-20
Study type(s) Interventional
Expected enrolment 690
Study start date 2014-02-24
Estimated primary completion date 2019-02-26

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