Clinical Trial

Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Study acronym: DIANER
Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2022-02-14; most recent amendment 2025-03-31.
Status change: Recruiting → Active, Not Recruiting 2024-11-18
Status change: Not Yet Recruiting → Recruiting 2022-11-29
Trial Details
NCT Number NCT05252988
Lead Sponsor Spanish Breast Cancer Research Group
Collaborators: Puma Biotechnology, Inc., Pierre Fabre Laboratories
Conditions Early-stage Breast Cancer, HER2 Positive Breast Cancer, Hormone Receptor Positive
Enrollment 177 participants
Start Date 2022-08-31
Primary Completion 2024-10-28 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-01