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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: 29 Jun 2020

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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 Chugai Pharmaceutical; Roche
  • Most Recent Events

    • 29 Jun 2020 According to a Roche media release, the US Food and Drug Administration (FDA) has approved fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer, based on the data from this trial.
    • 01 Apr 2020 Planned End Date changed from 27 Feb 2024 to 26 May 2023.
    • 20 Mar 2020 This trial has been completed in Germany, according to European Clinical Trials Database. (2019-02-07)
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