OncoMatch/Clinical Trials/NCT06949410
HER2 Vaccine for Locally Advanced Breast Cancer
Is NCT06949410 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies HER2 Vaccine for breast cancer.
Treatment: HER2 Vaccine — The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (HER2 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of > 2.0 or > 6 total HER2 gene copies per cell)
HER2 positive is defined as HER2 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of > 2.0 or > 6 total HER2 gene copies per cell
Disease stage
Required: Stage III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab, TDM-1, neratinib) — neoadjuvant or adjuvant
Received at least six months of HER2 targeted therapy with trastuzmab +/- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting; Any combination of HER2 targeted therapy in the curative setting is allowed, including neratinib or others on a clinical trial
Cannot have received: CDK4/6 inhibitor
Patients receiving or planned to receive adjuvant CDK4/6 inhibitor therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) > 1.0 K/mm3; Platelets > 100 K/mm3
Kidney function
Calculated creatinine clearance of > 60 mL/min using the Cockcroft-Gault formula
Liver function
Total bilirubin < 1.5 mg/dL (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL); AST and ALT < 2.0 x ULN
Cardiac function
Adequate cardiac function defined as left ventricular ejection fraction (LVEF) above the institutional lower limit of normal by echocardiogram or MUGA obtained within 90 days of registration
Adequate organ function as indicated by: Total bilirubin < 1.5 mg/dL (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL); AST and ALT < 2.0 x ULN; Calculated creatinine clearance of > 60 mL/min using the Cockcroft-Gault formula; Absolute neutrophil count (ANC) > 1.0 K/mm3; Platelets > 100 K/mm3; Adequate cardiac function defined as left ventricular ejection fraction (LVEF) above the institutional lower limit of normal by echocardiogram or MUGA obtained within 90 days of registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Indiana University Melvin & Bren Simon Comprehensive Cancer Center · Indianapolis, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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