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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

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Pertuzumab/trastuzumab (Primary) ; Aromatase inhibitors; Cyclophosphamide; Docetaxel; Doxorubicin; Paclitaxel; Pertuzumab; Tamoxifen; Trastuzumab; Trastuzumab
  • Indications Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Pharmacokinetics; Registrational
  • Acronyms FeDeriCa
  • Sponsors Chugai Pharmaceutical; Roche

Most Recent Events

  • 30 Apr 2025 According to Roche media release, the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo, a subcutaneous (SC) fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer, A final decision regarding the approval is expected from the European Commission in the near future.
  • 25 Sep 2023 According to a Chugai Pharmaceutical media release, company announced Phesgo, a fixed-dose combination of Perjeta and Herceptin for subcutaneous injection, receives manufacturing and marketing approval for HER2-positive breast cancer and colorectal cancer and this approval is based on an international joint phase III clinical trial (FeDeriCa study) and (PHranceSCa study).
  • 03 Sep 2023 This trial has been completed in Belgium, according to European Clinical Trials Database record.

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