MedTrace Logo

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

NCT05252988 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Neratinib

Neratinib orally once daily for 13 cycles, unless patient discontinues earlier.

DRUG

Loperamide

Loperamide orally.

DRUG

Colesevelam

Colesevelam capsules orally, 2 times a day for the first month (28 days).

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    collaborator INDUSTRY

  • Pierre Fabre Laboratories

    collaborator INDUSTRY

  • Spanish Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Study Director Study Director · Hospital General Universitario Gregorio Marañón

  • Study Director Study Director · Insititut Català d'Oncologia de L'Hospitalet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-10-28
Completion
2030-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05252988 on ClinicalTrials.gov