A Randomized, Double-blind Pharmacokinetic Study Of Pf-05280014 Plus Taxotere (Registered) And Carboplatin Versus Herceptin (Registered) Plus Taxotere (Registered) And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable Her2-positive Breast Cancer

Trial Profile

A Randomized, Double-blind Pharmacokinetic Study Of Pf-05280014 Plus Taxotere (Registered) And Carboplatin Versus Herceptin (Registered) Plus Taxotere (Registered) And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable Her2-positive Breast Cancer

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Trastuzumab (Primary) ; Carboplatin; Docetaxel
  • Indications Early breast cancer
  • Focus Pharmacokinetics; Registrational
  • Acronyms REFLECTION B327-04; REFLECTIONS B327-04
  • Sponsors Pfizer
  • Most Recent Events

    • 12 Sep 2017 Results assessing pharmacokinetics, efficacy, immunogenicity and tolerability of neoadjuvant administration of two different trastuzumab formulations - trastuzumab biosimilar [PF-05280014] versus Herceptin, each with docetaxel and carboplatin, in female patients with HER2+ breast cancer, were presented at the 42nd European Society for Medical Oncology Congress.
    • 10 Sep 2017 Positive data from this supplemental study presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, according to a Pfizer media release.
    • 30 Nov 2016 Primary endpoint has been met. (Percentage of patients with steady state drug concentration Cycle 5 Ctrough (Cycle 6 pre-dose) 20 g/mL between trastuzumab-Pfizer versus Herceptin)
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