Benmelstobart plus antiangiogenic therapy vs chemotherapy for metastatic triple-negative breast cancer: phase III trial

This open-label phase III trial assessed a chemotherapy-free regimen for recurrent/metastatic triple-negative breast cancer (TNBC). Patients were 1:1 randomized to benmelstobart plus anlotinib or nab-paclitaxel monotherapy, stratified by prior taxane exposure, liver and brain metastases. Planned enrollment was 322, yet recruitment was prematurely stopped by COVID-19, leaving only 147 randomized participants (75 experimental, 72 control). All efficacy analyses are exploratory and require cautious interpretation. The primary endpoint, IRC-assessed progression-free survival (PFS), was not met. Investigator-assessed median PFS reached 7.85 months for the combination vs. 5.55 months for nab-paclitaxel (HR = 0.70, 95%CI 0.46–1.06, P = 0.1687). Median overall survival (OS) was 35.81 vs. 21.03 months (HR = 0.78, 95%CI 0.49–1.24, P = 0.2625). Grade ≥3 treatment-related adverse events affected 58.7% of combination patients and 36.6% of monotherapy patients. This regimen failed to deliver statistically superior clinical benefits over nab-paclitaxel, only showing a non-significant favorable trend. Further trials are warranted to validate this observation. Trial ID: NCT04405505, registered May 24, 2020 on ClinicalTrials.gov.

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Journal
npj Breast Cancer
Published
2026-09-04
DOI
https://doi.org/10.1038/s41523-026-01045-5
Primary Topic
Angiogenesis and VEGF in Cancer
Type
article
Field-Weighted Citation Impact
0.00

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article

Benmelstobart plus antiangiogenic therapy vs chemotherapy for metastatic triple-negative breast cancer: phase III trial

Hongyan Ying, Fuming Qiu, Xunqiang WANG, Xiaojia Wang et al.
npj Breast Cancer
Angiogenesis and VEGF in Cancer
article

Benmelstobart plus antiangiogenic therapy vs chemotherapy for metastatic triple-negative breast cancer: phase III trial

Hongyan Ying, Fuming Qiu, Xunqiang WANG, Xiaojia Wang, Binghe Xu, Quchang Ouyang, Yuee Teng, Tao Sun, Yunhong Xia, Ning Liao, Zhihong Wang, Jincai Zhong, Xiaohua Zeng, Xiaoyan Li, Qingyuan Zhang, Yahua Zhong, Wenxian Zhou, Jiayu Wang, Lu Gan, Huadong Zhao, Cuizhi Geng, Yu Ren, Zhongsheng Tong, Jing Sun
article en

Abstract

This open-label phase III trial assessed a chemotherapy-free regimen for recurrent/metastatic triple-negative breast cancer (TNBC). Patients were 1:1 randomized to benmelstobart plus anlotinib or nab-paclitaxel monotherapy, stratified by prior taxane exposure, liver and brain metastases. Planned enrollment was 322, yet recruitment was prematurely stopped by COVID-19, leaving only 147 randomized participants (75 experimental, 72 control). All efficacy analyses are exploratory and require cautious interpretation. The primary endpoint, IRC-assessed progression-free survival (PFS), was not met. Investigator-assessed median PFS reached 7.85 months for the combination vs. 5.55 months for nab-paclitaxel (HR = 0.70, 95%CI 0.46–1.06, P = 0.1687). Median overall survival (OS) was 35.81 vs. 21.03 months (HR = 0.78, 95%CI 0.49–1.24, P = 0.2625). Grade ≥3 treatment-related adverse events affected 58.7% of combination patients and 36.6% of monotherapy patients. This regimen failed to deliver statistically superior clinical benefits over nab-paclitaxel, only showing a non-significant favorable trend. Further trials are warranted to validate this observation. Trial ID: NCT04405505, registered May 24, 2020 on ClinicalTrials.gov.

npj Breast Cancer
Hebei Medical University (CN), Guiyang Medical University (CN), Harbin Medical University (CN), Chongqing University (CN), Guangxi Medical University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Guangdong General Hospital (CN), Peking Union Medical College Hospital (CN), Tianjin Medical University Cancer Institute and Hospital (CN), Wuhan University (CN), Beijing Tian Tan Hospital (CN), People 's Liberation Army 451 Hospital (CN), Zhejiang Cancer Hospital (CN), Guizhou Cancer Hospital (CN), Third Affiliated Hospital of Harbin Medical University (CN), Fourth Hospital of Hebei Medical University (CN), Hunan Cancer Hospital (CN), Zhongnan Hospital of Wuhan University (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), First Affiliated Hospital of GuangXi Medical University (CN), The Affiliated Yongchuan Hospital of Chongqing Medical University (CN), Chongqing Cancer Hospital (CN), Tumor Hospital of Guangxi Medical University (CN), Second Affiliated Hospital of Zhejiang University (CN), Liaoning Cancer Hospital & Institute (CN), Anyang Tumor Hospital (CN), First Hospital of Xi'an (CN), Chongqing Medical University (CN), China Medical University (CN)
Chinese Academy of Medical Sciences, National Science and Technology Major Project
Good health and well-being
Openalex Percentile: Top 18%
Angiogenesis and VEGF in Cancer
DOIOpen Access PDFOpenAlex
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