Original Investigation

Neoadjuvant Anbenitamab and HB1801 in ERBB2-Positive Breast Cancer

JAMA Oncology 10.1001/jamaoncol.2026.3329

September 03, 2026 at 11:00 AM EDT

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Does the combination of ERBB2-biparatopic antibody (anbenitamab) and albumin-bound docetaxel (HB1801) increase the total pathological complete response (tpCR) rate compared with the standard regimen of trastuzumab, pertuzumab, and docetaxel in patients with ERBB2-positive breast cancer? In this randomized clinical trial that included 521 patients with early or locally advanced ERBB2-positive breast cancer, the tpCR rate was significantly higher in the anbenitamab and HB1801 group compared with the control group; both regimens had manageable safety profiles. These findings suggest that neoadjuvant anbenitamab and HB1801 led to clinically meaningful tpCR improvement; this new combination might establish a new standard for neoadjuvant treatment in ERBB2-positive breast cancer.

Corresponding Authors: Zhi-Ming Shao, MD, (zhimin_shao@yeah.net), and Lei Fan, MD, (teddyfl@163.com), Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Rd, Shanghai, 200032, China

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