OncoMatch/Clinical Trials/NCT04965064
Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling
Is NCT04965064 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Capecitabine and Neratinib. for breast cancer.
Treatment: Capecitabine and Neratinib. — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type
Histologically confirmed HER2 negative breast cancer determined from the most recent tumor sample (primary or metastatic), as per the current American Society of Clinical Oncology and College of American Pathologists HER2 testing guidelines.
Required: HER2 (ERBB2) abnormally active signaling
Abnormally active HER2 signaling as determined by the CELsignia test on the tumor tissue.
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CDK4/6 inhibitor — metastatic
For ER positive breast cancer patients: prior treatment with a CDK4/6 inhibitor and endocrine therapy in required in the metastatic settings. If a patient has received a CDK4/6 inhibitor plus endocrine therapy in the adjuvant settings and the cancer recurred while on the CDK4/6 inhibitor or within 12 months of the end of CDK4/6 inhibitor treatment, then the patient will eligible without getting a CDK4/6 inhibitor and endocrine therapy in the metastatic setting.
Must have received: endocrine therapy — metastatic
For ER positive breast cancer patients: prior treatment with a CDK4/6 inhibitor and endocrine therapy in required in the metastatic settings. If a patient has received a CDK4/6 inhibitor plus endocrine therapy in the adjuvant settings and the cancer recurred while on the CDK4/6 inhibitor or within 12 months of the end of the CDK4/6 inhibitor treatment, then the patient will eligible without getting a CDK4/6 inhibitor and endocrine therapy in the metastatic setting.
Cannot have received: capecitabine (capecitabine)
Exception: capecitabine only in the perioperative setting for the primary early-stage breast cancer AND the breast cancer did NOT recur while taking capecitabine or within 180 days of the last dose of capecitabine therapy
Patients who have received capecitabine for the treatment of the current breast cancer in the metastatic setting; Patients who have received capecitabine only in the perioperative setting for the primary early-stage breast cancer AND the breast cancer recurred while taking capecitabine or within 180 days of the last dose of capecitabine therapy.
Lab requirements
Blood counts
Adequate bone marrow function
Kidney function
Adequate renal function
Liver function
Adequate hepatic function
Cardiac function
Left ventricular ejection fraction ≥ 50% at baseline; Serious cardiac illness or condition [excluded]
Adequate bone marrow, hepatic, renal, and coagulation function; Left ventricular ejection fraction ≥ 50% at baseline; Serious cardiac illness or condition including, but not limited to, clinically significant congestive heart failure, high-risk uncontrolled arrhythmias, unstable angina pectoris requiring medication, or clinically significant valvular heart disease [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Rochester · Rochester, New York
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