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A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer

Trial Profile

A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer

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

Latest Information Update: 18 Nov 2019

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At a glance

  • Drugs Pertuzumab/trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Doxorubicin; Paclitaxel; Pertuzumab; Trastuzumab; Trastuzumab
  • Indications Early breast cancer; Male breast cancer
  • Focus Pharmacokinetics; Registrational
  • Acronyms FeDeriCa
  • Sponsors Roche
  • Most Recent Events

    • 18 Nov 2019 According to a Genentech media release, primary analysis data from this trial will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019.
    • 13 Sep 2019 Results presented in a Genentech Media Release.
    • 13 Sep 2019 According to a Halozyme Therapeutics media release, full data from this study will be submitted for presentation at an upcoming medical meeting and to health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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