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A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus Loperamide prophylaxis versus Neratinib with Initial Dose Escalation plus PRN Loperamide prophylaxis versus Neratinib plus Loperamide plus Colesevelam prophylaxis

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Trial Profile

A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus Loperamide prophylaxis versus Neratinib with Initial Dose Escalation plus PRN Loperamide prophylaxis versus Neratinib plus Loperamide plus Colesevelam prophylaxis

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

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Colesevelam (Primary) ; Loperamide (Primary) ; Neratinib (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Diarrhoea; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions
  • Acronyms DIANER

Most Recent Events

  • 19 Nov 2024 Status changed from recruiting to active, no longer recruiting.
  • 02 Feb 2024 Study design discussed in an abstract published in 46th Annual San Antonio Breast Cancer Symposium.
  • 30 Nov 2023 Planned primary completion date changed from 1 Dec 2023 to 25 Mar 2025.

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