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A Multicenter, Double-Blind, Randomized, Parallel- Group, Active-Controlled, Two Part, Phase III, Global Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BP02 (Trastuzumab) in comparison with Herceptin®-EU in Patients with HER2-Positive Early Breast Cancer (EBC) and HER2-Positive Metastatic Breast Cancer (MBC).

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Trial Profile

A Multicenter, Double-Blind, Randomized, Parallel- Group, Active-Controlled, Two Part, Phase III, Global Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BP02 (Trastuzumab) in comparison with Herceptin®-EU in Patients with HER2-Positive Early Breast Cancer (EBC) and HER2-Positive Metastatic Breast Cancer (MBC).

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2020

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At a glance

  • Drugs Docetaxel (Primary) ; Trastuzumab (Primary)
  • Indications Advanced breast cancer; Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Aurobindo Pharma; CURATEQ BIOLOGICS PRIVATE LIMITED

Most Recent Events

  • 04 Nov 2020 Status changed from not yet recruiting to recruiting.
  • 31 Jul 2020 New trial record

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