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A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

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Trial Profile

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jan 2023

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At a glance

  • Drugs Netupitant/palonosetron (Primary) ; Dexamethasone; Netupitant/palonosetron
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Helsinn Healthcare SA

    • Most Recent Events

    • 04 Jan 2023 According to an Helsinn Media release, results from secondary analysis have been published in The Oncologist.
    • 04 Jan 2023 Results from secondary analysis published in the Helsinn Media Release.
    • 11 Dec 2020 Results presented at the 43rd Annual San Antonio Breast Cancer Symposium
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