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A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

Trial Profile

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2019

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At a glance

  • Drugs Neratinib (Primary) ; Capecitabine; Lapatinib
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NALA
  • Sponsors Puma Biotechnology
  • Most Recent Events

    • 07 Nov 2019 This trial has been completed in Portugal, according to European Clinical Trials Database.
    • 06 Oct 2019 According to European Clinical Trials Database record, trial is completed in Finland, Denmark, Belgium, Czech Republic, Austria, and Sweden.
    • 11 Sep 2019 According to a Puma Biotechnology media release, the FDA has informed the Company that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA confirmed that the review will have an action date of late April, 2020.
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