HER2/EGFR in Cancer Research
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Abstract
Abstract
Strategies are needed to avoid chemotherapy in early stage HER2-positive (HER2 + ) breast cancer (BC). We conducted a neoadjuvant therapy trial with zanidatamab, a dual HER2-directed bispecific antibody, in patients with 1-3 cm, node-negative HER2 + BC. Primary endpoint was pathologic complete response (pCR). Secondary endpoints were radiographic response by ultrasound and magnetic resonance imaging. US and MRI, pathologic response by residual cancer burden (RCB), rate of adverse events, feasibility of accrual and biomarkers of response. Fifteen patients with HER2 IHC 3 + , and 5 with HER2 IHC 2 + /ISH + BC were enrolled. Patients received zanidatamab 20 mg/kg every 2 weeks for 6 (n = 11) or 10 doses (n = 9). Fourteen patients also received endocrine therapy. At 6 weeks, there was a significant decrease in tumor size and volume. At surgery, six patients (30%) had pCR, meeting the prespecified pCR target, and four had limited RCB (RCB-1; 20%). Treatment was well tolerated. All patients with pCR had HER2 IHC 3+ tumors, ERBB2 amplification on WES, PAM50 HER2-high subtype, and a trend towards higher HER2 mRNA expression (p = 0.06). In conclusion, de-escalation to HER2-targeted therapy alone may be feasible. Further research is needed to refine patient selection. This study is registered at ClinicalTrials.gov (NCT05035836). With the improvement of HER2-targeted therapy in patients with breast cancer, there is growing interest in whether chemotherapy can be eliminated from regimens completely. Here, the authors report a phase 2 clinical trial investigating neoadjuvant zanidatamab (HER2-targeting antibody) in patients with early-stage HER2-positive breast cancer.
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@article{Valero2026Zanidatamab,
title = {Zanidatamab in patients with early stage HER2-positive breast cancer: the NeoZanHER phase 2 single-arm open-label trial},
author = {Vicente Valero and Paula R. Pohlmann and Jason Mouabbi and Xuelin Huang and Wei Qiao and H. Alonzo and Rashmi K. Murthy and Gaiane M. Rauch and Taiwo Adesoye and Cristina Checka and W. Fraser Symmans and D. A. Grachev and Flora Alajajyan and Adaeze Nwosu-Iheme and Amy Hassan and Miral Patel and Sharon H. Giordano and Kelly K. Hunt and Debu Tripathy and Funda Meric‐Bernstam},
journal = {Nature Communications},
year = {2026},
doi = {10.1038/s41467-026-76662-6},
url = {https://doi.org/10.1038/s41467-026-76662-6}
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