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A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer

Trial Profile

A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Carboplatin (Primary) ; Docetaxel (Primary) ; Pertuzumab (Primary) ; Trastuzumab (Primary)
  • Indications Early breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Biocon Biologic

Most Recent Events

  • 25 Jun 2025 Status changed from not yet recruiting to recruiting.
  • 17 Dec 2024 Planned initiation date changed from 15 Sep 2024 to 31 Jan 2025.
  • 15 Apr 2024 Planned initiation date changed from 15 Mar 2024 to 15 Sep 2024.

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