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◆ Nature communications2026-08-22

Zanidatamab in patients with early stage HER2-positive breast cancer: the NeoZanHER phase 2 single-arm open-label trial.

Vicente Valero, Paula R Pohlmann, Jason Mouabbi, Xuelin Huang, Wei Qiao, Heather Alonzo, Rashmi K Murthy, Gaiane M Rauch, Taiwo Adesoye, Cristina Checka, Fraser W Symmans, Dmitrii Grachev, Flora Alajajyan, Adaeze Nwosu-Iheme, Amy Hassan, Miral Patel, Sharon H Giordano, Kelly Hunt, Debasish Tripathy, Funda Meric-Bernstam

一句话结论 · In one sentence

Female participation at the 43rd Workshop CAEK was well balanced, although the gender of the first questioner influenced subsequent audience engagement, as observed in other studies. These findings suggest equitable academic engagement in endocrine surgery in Germany, while indicating that the gender of the first questioner is associated with subsequent audience participation.

原始摘要(英文原文)· Original 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).
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Zanidatamab in patients with early stage HER2-positive breast cancer: the NeoZanHER phase 2 single-arm open-label trial. — 科研速览 Science Skim