An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Intensive Loperamide Prophylaxis

Trial Profile

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Intensive Loperamide Prophylaxis

Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Jun 2018

At a glance

  • Drugs Neratinib (Primary) ; Budesonide; Colestipol; Loperamide
  • Indications Adenocarcinoma; Early breast cancer
  • Focus Adverse reactions; Registrational
  • Acronyms CONTROL
  • Sponsors Puma Biotechnology
  • Most Recent Events

    • 26 Jun 2018 According to a Puma Biotechnology media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive trend vote recommending the approval of the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer.
    • 09 May 2018 Puma Biotechnology expects a re-assessment of the Marketing Authorisation Application for neratinib by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in mid-2018, according to a Company media release.
    • 01 Mar 2018 According to a Puma Biotechnology media release, the company expects to report additional data from this trial in the fourth quarter of 2018.
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