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)
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 |