drugset / Trial / NCT04965064

Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

NCT04965064

Phase 2 Recruiting 22 enrolled University of Rochester
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were HER2-negative by standard tests but showed abnormal HER2 activity based on the CELsignia results.

Timeline

Start
2022-09-23
Primary completion
2026-09-01
Completion
2027-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Neratinib Small molecule 240 mg Oral

Indications