Overview

Trial to Evaluate Diarrhoea Discontinuations at 3 Cycles in Patients With Early-stage HER2+, HR+ Breast Cancer Treated With Neratinib Plus Loperamide Versus Neratinib Dose Escalation Plus Loperamide Administered as Needed Versus Neratinib Plus Loper

Status:
Not yet recruiting

Trial end date:
2030-01-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Spanish Breast Cancer Research Group

Collaborators:

Pierre Fabre Laboratories
Puma Biotechnology, Inc.

Treatments:

Antidiarrheals
Colesevelam Hydrochloride
Loperamide