Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

This is A prospective, randomized, single-center clinical trial, divided into 3 groups (experimental group: group A and group B, control group: group C), planned sixty patients were enrolled, with 20 patients in each group. Experimental group: Group A (n=20) and group B (n=20) were given neratinib dose escalation regimen foranti-HER2 adjuvant therapy.In group A, the dose of neratinib climbed up to 240mg within 2 weeks, and in group B, the dose climbed up to 240mg within 4 weeks. Control group: Group C (n=20) was given 240mg neratinib initially, but prophylactic loperamide antidiarrhea treatment was given at the same time within 2 months. Diarrhea caused by neratinib often occurred within 1-2 months of initial treatment, so small dose of neratinib was used in both group A and group B at the time of initial treatment. The incidence and severity of neratinib-related diarrhea in the three groups were observed, and DFS and other neratinib-related adverse events were followed up for a long time. The study is to evaluate the safety and efficacy of neratinib dose escalation regimen and conventional dose combined with loperamide regimen in enhanced anti-HER2 adjuvant therapy for early HER2-positive breast cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05154396
Study type	Interventional
Source	Chinese Academy of Medical Sciences
Contact	Peng Yuan
Phone	01087787245
Email	yuanpengyp01@163.com
Status	Not yet recruiting
Phase	Phase 2
Start date	January 1, 2022
Completion date	December 31, 2024

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See also
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