Article
作者: Zhang, Shuqun ; Wang, Xiaochun ; Ren, Yu ; Yu, Zhigang ; Xiang, Silong ; Liu, Chunping ; Guo, Wenhui ; Tao, Wei ; Sun, Tao ; Kong, Xiangshun ; Wang, Zhihong ; Mu, Qiang ; Wu, Xiaobo ; Zhang, Hao ; Lai, Guie ; Song, Dong ; Zhou, Xin ; Shao, Zhi-Ming ; Hou, Xiaoke ; Qian, Hesheng ; Wu, Zhiyong ; Li, Huiping ; Wang, Shu ; Song, Zhenchuan ; Bai, Xiaorong ; Zhang, Yu ; Wu, Tao ; Guo, Yanxiang ; Li, Junjie ; Zhang, Yiwen ; Yu, Yang ; Ru, Chen ; Jiang, Xuemei ; Ma, Xiaopeng ; Yang, Hongwei ; Yin, Guobing ; Luo, Jing ; Zhu, Jinhai ; Fan, Lei ; Fu, Peifen ; Li, Nanlin ; Yao, Guangyu ; Ji, Peng ; Zhu, Zhijun ; Yang, Huawei ; Cui, Shien ; Xu, Fei ; Yao, Fan ; Bing, Dai ; Fan, Pingming ; Zeng, Yi ; Zhou, Li ; Huang, Zhen ; Zou, Kai ; Wang, Jingfen ; Ouyang, Zhong ; Hu, Xiaobo ; Yao, Yongzhong ; Dong, Yuan ; Han, Guohui ; He, Hang ; Li, Taolang ; Huang, Wei ; Xiong, Dun ; Nie, Jianyun ; Yu, Ke-Da ; Liu, Tong ; Jia, Hongyan ; Lv, Ye ; Deng, Chao ; Jia, Haiquan
IMPORTANCE:
The combination of neoadjuvant taxanes with trastuzumab and pertuzumab remains the cornerstone treatment strategy in
ERBB2
-positive breast cancer. Anbenitamab (a
ERBB2
-biparatopic antibody that induces profound receptor clustering) and HB1801 (a solvent-free albumin-bound docetaxel), have shown promising antitumor activity and an acceptable safety profile in patients with breast cancer.
OBJECTIVE:
To evaluate whether neoadjuvant anbenitamab combined with HB1801 could improve efficacy without increasing toxic effects for patients with early
ERBB2
-positive breast cancer.
DESIGN, SETTING, AND PARTICIPANTS:
This multicenter, phase 3 registrational randomized clinical trial enrolled patients with stage II or III
ERBB2
-positive breast cancer from 61 hospitals in China between December 19, 2024, and August 29, 2025 (data cutoff: January 28, 2026). Data were analyzed from February 1 to March 20, 2026.
INTERVENTIONS:Patients were randomly assigned (1:1) to receive 6 cycles of neoadjuvant anbenitamab plus HB1801, with or without carboplatin (investigational group), or trastuzumab, pertuzumab, and docetaxel, with or without carboplatin (control group).
MAIN OUTCOMES AND MEASURES:The primary end point was total pathological complete response (tpCR) assessed by a blinded independent review committee.
RESULTS:
Among 521 included patients (median [IQR] age, 52.0 [23-79] years), 263 were randomized to the investigational group and 258 to the control group. The tpCR rate was significantly higher in the investigational group than the control group (164 patients [62.4%] vs 132 patients [51.2%]; absolute difference, 11.4 [95% CI, 3.2 to 19.6] percentage points;
P
= .004). Benefit was consistent across subgroups, including subgroups with hormone receptor–positive disease (77 patients [51.7%] vs 63 patients [44.4%]), hormone receptor–negative disease (87 patients [76.3%] vs 69 patients [59.5%]), early-stage disease (111 patients [63.8%] vs 87 patients [51.8%]), locally advanced disease (53 patients [59.6%] vs 45 patients [50.0%]), with carboplatin treatment (74 patients [66.7%] vs 61 patients [54.5%]), and without carboplatin treatment (90 patients [59.2%] vs 71 patients [48.6%]). Grade 3 or 4 treatment-related adverse events occurred in 77 patients (29.3%) in the investigational group and 73 patients (28.3%) of the control group. No treatment-related deaths occurred.
CONCLUSIONS AND RELEVANCE:This randomized clinical trial found that neoadjuvant anbenitamab and HB1801 in patients with breast cancer significantly improved the tpCR rate compared with standard therapy with a highly manageable safety profile. This new combination may offer an improved treatment option, although long-term survival follow-up analyses are warranted.
Trial Registration:
ClinicalTrials.gov Identifier:
NCT06747338