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An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

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An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Pertuzumab/trastuzumab (Primary) ; Pertuzumab/trastuzumab (Primary)
  • Indications Advanced breast cancer; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions; Expanded access
  • Sponsors Genentech

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.
  • 29 Jun 2022 Status changed from recruiting to completed.
  • 07 Jun 2022 Preliminary analysis (data cut off: Jan 19, 2022; n=114) presented at the 58th Annual Meeting of the American Society of Clinical Oncology

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