NCT04965064

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The CELsignia test results might predict whether this breast cancer type will respond to treatment with neratinib and capecitabine. Neratinib is called a HER2-targeted therapy because it stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow. Neratinib is an oral drug approved by the U.S. Food and Drug Administration (FDA) to treat HER2-positive breast cancer. It is considered investigational in this study because your breast cancer was determined to be HER2-negative by the standard method of testing. However, the CELsignia test showed that your breast cancer cells have HER2 pathway activity that might respond to HER2-targeted treatment.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-23
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2021-07-16
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study