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Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

NCT05154396 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-13

No results posted yet for this study

Summary

This is a prospective study on the prevention of Neratinib-related diarrhea in a Chinese population, exploring the best options for reducing the incidence of neratinib-related diarrhea through either pharmacologic intervention (prophylactic antidiarrheal therapy) or non-pharmacologic intervention (dose escalation program).

Conditions

Interventions

DRUG

Neratinib

Patients with her2-positive early breast cancer were treated with a dose escalation regimen of neratinib or a routine dose of neratinib combined with loperamide

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Peng Yuan · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-31
Completion
2024-12-31

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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 NCT05154396 on ClinicalTrials.gov