Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-07-14; most recent amendment 2025-12-06.
Status change: Not Yet Recruiting → Recruiting 2022-09-23
Trial Details
NCT Number NCT04965064
Lead Sponsor University of Rochester
Conditions Breast Cancer
Enrollment 22 participants
Start Date 2022-09-23
Primary Completion 2026-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-15