Actively Recruiting
Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling
Led by University of Rochester · Updated on 2025-12-15
22
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients
- At least 18 years old
- Histologically confirmed HER2-negative breast cancer by current testing guidelines
- For ER-positive breast cancer, prior treatment with a CDK4/6 inhibitor and endocrine therapy in the metastatic setting or as specified for recurrence
- No specific prior treatment required for triple negative breast cancer
- Radiological evidence of one or more brain metastases
- Ability to have MRI scans
- Measurable disease outside the brain accessible for biopsy
- Willingness and medical fitness to undergo a research core tumor biopsy
- Candidate for systemic therapy now or in the future
- Abnormally active HER2 signaling by CELsignia test
- New or progressive brain metastases based on defined criteria
- Measurable brain metastases with at least one lesion larger than 5 mm
- No major surgery within 10 days prior to registration
- Specific timing intervals since last chemotherapy, hormonal therapy, targeted therapy, radiation, investigational treatments
- ECOG performance status 0 to 2
- Left ventricular ejection fraction 50% or higher
- Recovery from prior major organ toxicities to grade 1 or less
- Adequate bone marrow, liver, kidney, and coagulation function
- Post-menopausal, surgically sterile, or willing to use contraception during and after study
- Ability to understand study risks and provide informed consent
You will not qualify if you...
- Prior capecitabine use for current metastatic breast cancer
- Capecitabine use only in perioperative setting with recurrence during or within 180 days after treatment
- History of other cancers except certain treated non-melanoma skin cancer, cervical in-situ cancer, or other solid tumors treated and no recurrence for 2 years
- Gastrointestinal conditions that prevent oral medication absorption
- Known allergy to study drugs or components
- Pregnant or breastfeeding
- Known or suspected leptomeningeal disease
- Bleeding or clotting disorders that increase biopsy bleeding risk
- Use of strong or moderate CYP3A4 inhibitors or inducers within 14 days before registration
- Uncontrolled medical conditions limiting study participation
- Inflammatory bowel disease with major diarrhea symptoms
- Normal or inconclusive HER2 signaling by CELsignia test
- Whole-brain radiotherapy within prior 3 months
- Poorly controlled or very high blood pressure
- Serious heart conditions including heart failure, unstable angina, arrhythmias, or significant valve disease
- Recent pulmonary embolus or deep vein thrombosis within 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
J
Jamie Littleton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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