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

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 Loperamide

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 25 Jul 2022

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At a glance

  • Drugs Neratinib (Primary) ; Budesonide; Colestipol; Loperamide
  • Indications Adenocarcinoma; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions; Registrational
  • Acronyms CONTROL
  • Sponsors Puma Biotechnology
  • Most Recent Events

    • 10 Dec 2021 According to a Pierre Fabre media release, this study final results were submitted to the European Medicines Agency in order to align the Product Information with the current scientific knowledge.
    • 10 Dec 2021 According to a Pierre Fabre media release, data were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS).
    • 10 Dec 2021 Results presented in a Pierre Fabre Media Release.
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