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A PHASE III, RANDOMIZED, ACTIVE CONTROLLED, ASSESSORBLINDED STUDY OF SAFETY AND EFFICACY OF PEGYLATED APOFILGRASTIM VERSUS US AND EU LICENSED NEULASTA IN SUBJECTS WITH STAGE IIA, IIB OR IIIA BREAST CANCER RECEIVING TAC ANTICANCER CHEMOTHERAPY IN ADJUVANT SETTING

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Trial Profile

A PHASE III, RANDOMIZED, ACTIVE CONTROLLED, ASSESSORBLINDED STUDY OF SAFETY AND EFFICACY OF PEGYLATED APOFILGRASTIM VERSUS US AND EU LICENSED NEULASTA IN SUBJECTS WITH STAGE IIA, IIB OR IIIA BREAST CANCER RECEIVING TAC ANTICANCER CHEMOTHERAPY IN ADJUVANT SETTING

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2018

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Ductal carcinoma; Febrile neutropenia
  • Focus Therapeutic Use
  • Sponsors Apotex

    • Most Recent Events

    • 27 Jul 2018 According to Accord Healthcare media release, The CHMP positive opinion was based on Pelgraz's substantial clinical development programme, which supported its biosimilarity with Neulasta through a Phase I, randomised, assessor-blinded PK/PD study in healthy volunteers, and a Phase III study of patients with breast cancer (stage IIa, IIb, or IIIa) on TAC (docetaxel, doxorubicin, cyclophosphamide).
    • 03 Nov 2014 New trial record
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