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A Phase 3, Double Blind, Randomized, Parallel Group, Active Controlled Study to Compare the Efficacy and Safety of CT P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients with HER2 Positive Early Breast Cancer

Trial Profile

A Phase 3, Double Blind, Randomized, Parallel Group, Active Controlled Study to Compare the Efficacy and Safety of CT P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients with HER2 Positive Early Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Aug 2022

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At a glance

  • Drugs Trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil
  • Indications Adenocarcinoma; Early breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Celltrion
  • Most Recent Events

    • 01 Aug 2021 Results assessing long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer published in the Breast Cancer Research and Treatment
    • 07 Aug 2019 Status changed from active, no longer recruiting to completed.
    • 05 Jun 2018 Pharmacokinetic results of CT-P6 and reference trastuzumab presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
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