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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2019

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At a glance

  • Drugs Trastuzumab (Primary) ; Paclitaxel
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms REFLECTIONS B327-02
  • Sponsors Pfizer
  • Most Recent Events

    • 24 Sep 2019 This trial has been completed in Portugal, according to European Clinical Trials Database record.
    • 21 Jun 2019 Planned End Date changed from 30 Jun 2020 to 31 May 2020.
    • 11 Mar 2019 According to a Pfizer media release, United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on review of a comprehensive data package including this study.
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