drugset / Trial / NCT05252988
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib
Phase 2
Active not recruiting
177 enrolled
Spanish Breast Cancer Research Group
Pierre Fabre Laboratories · collabPuma Biotechnology, Inc. · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2022-08-31
- Primary completion
- 2024-10-28
- Completion
- 2030-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colesevelam | Other / unclassified | 1875 mg | Oral |
| Subject | Loperamide | Small molecule | 4 mg | Oral |
| Subject | Neratinib | Small molecule | 240 mg | Oral |