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: 12 Aug 2017

At a glance

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

    • 09 Aug 2017 According to Puma Biotechnology media release, additional data from this trial will be reported in fourth quarter of 2017.
    • 05 Apr 2017 Results (n=186) presented at the 108th Annual Meeting of the American Association for Cancer Research
    • 04 Apr 2017 Interim results (n=137) published in a Puma Biotechnology media release Media Release.
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