OncoMatch/Clinical Trials/NCT05035836
A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)
Is NCT05035836 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Zanidatamab and Letrozole for breast cancer.
Treatment: Zanidatamab · Letrozole · Tamoxifen — This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR) .
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification (HER2+ as defined by ASCO-CAP guidelines)
HER2+ BC as defined by American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any therapy for current diagnosis of breast cancer
Has received therapy for this current diagnosis of BC including investigational therapy, endocrine therapy, targeted therapy, or chemotherapy, surgery or radiation
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 x 10^9/L (≥ 1500 per mm3); Platelet count ≥ 100 x 10^9/L (≥100,000 per mm3)
Kidney function
Calculated glomerular filtration rate >50 mL/min
Liver function
Serum bilirubin ≤ 1.5 x institutional ULN (≤ 2.5 x ULN for Gilbert's disease); AST and ALT ≤ 3 x institutional ULN
Cardiac function
Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by ECHO or MUGA scan, documented within 4 weeks prior to first dose of study drug
Adequate normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1.5 x 10^9/L (≥ 1500 per mm3); Platelet count ≥ 100 x 10^9/L (≥100,000 per mm3); Serum bilirubin ≤ 1.5 x institutional ULN (≤ 2.5 x ULN for Gilbert's disease); AST and ALT ≤ 3 x institutional ULN; Calculated glomerular filtration rate >50 mL/min; LVEF must be within institutional limits of normal as assessed by ECHO or MUGA scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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