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

NCT04965064 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Capecitabine and Neratinib.

Neratinib 240 mg PO QD Daily On-going Capecitabine 750 mg/m2 PO bid Days 1-14, 7 days off On-going

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Ajay Dhakal · University of Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2026-09-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

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 NCT04965064 on ClinicalTrials.gov