Date: 2013-10-28
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Pfizer (USA - NY)
Product: PF-05280014 [Trastuzumab-Pfizer]
Action
mechanism: biosimilar/monoclonal antibody. Trastuzumab is a recombinant humanized monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2). After binding to HER2 on the tumor cell surface, trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.
Disease: metastatic breast cancer
Therapeutic area: Cancer - Oncology
Country: Argentina, Brazil, Chile, Czech Republic, Greece, Hungary, India, Japan, Republic of Korea, Latvia, Mexico, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Thailand, Turkey, Ukraine, Paraguay, Puerto Rico, Singapore, Spain, USA
Trial
details: The REFLECTIONS B327-02 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.(NCT01989676 )
Latest
news: * On October 28, 2013, a Phase 3 trial sponsored by Pfizer was published on the NIH website ClinicalTrials.gov for PF-05280014 [Trastuzumab-Pfizer] and is currently recruiting participants.
