Bireociclib plus fulvestrant for HR+/HER2- advanced female breast cancer progressed on or after endocrine therapy: phase 3 BRIGHT-2 study interim analysis

Jiayu Wang, Qingyuan Zhang, Huiping Li, Zhongsheng Tong, Quchang Ouyang, Huihui Li, Yuee Teng, Biyun Wang, Tao Sun, Jingfen Wang, Wei Li, Zhaofeng Niu, Hongsheng Li, Chang Gong, Shu Wang, Xinshuai Wang, Xinhong Wu, Ning Liu, Guohua Yu, Fei Liu, Xianghui Duan, Shuya Wang, Yaping Meng, Li Wang and Binghe Xu ()
Additional contact information
Jiayu Wang: Chinese Academy of Medical Sciences and Peking Union Medical College
Qingyuan Zhang: Harbin Medical University Cancer Hospital
Huiping Li: Peking University Cancer Hospital and Institute
Zhongsheng Tong: Tianjin Medical University Cancer Institute and Hospital
Quchang Ouyang: Hunan Cancer Hospital
Huihui Li: Shandong First Medical University and Shandong Academy of Medical Sciences
Yuee Teng: The First Hospital of China Medical University
Biyun Wang: Fudan University Shanghai Cancer Center
Tao Sun: Liaoning Cancer Hospital
Jingfen Wang: Linyi Cancer Hospital
Wei Li: The First Affiliated Hospital of Jilin University
Zhaofeng Niu: Yuncheng Central Hospital
Hongsheng Li: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Chang Gong: Sun Yat-sen University
Shu Wang: Peking University People’s Hospital
Xinshuai Wang: Medical College of Henan University of Science and Technology
Xinhong Wu: and Wuhan Clinical Research Center for Breast Cancer
Ning Liu: Jining No. 1 People’s Hospital
Guohua Yu: Weifang People’s Hospital
Fei Liu: Xuanzhu Biopharmaceutical Co.Ltd.
Xianghui Duan: Xuanzhu Biopharmaceutical Co.Ltd.
Shuya Wang: Xuanzhu Biopharmaceutical Co.Ltd.
Yaping Meng: Xuanzhu Biopharmaceutical Co.Ltd.
Li Wang: Xuanzhu Biopharmaceutical Co.Ltd.
Binghe Xu: Chinese Academy of Medical Sciences and Peking Union Medical College

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract The BRIGHT-2 study (NCT05077449) is a randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of bireociclib plus fulvestrant (BF) vs. placebo plus fulvestrant (F) in Chinese female patients with hormone receptor-positive (HR+)/HER2-negative (HER2-) advanced breast cancer (ABC) who had progressed on or after prior endocrine therapy (ET). Interim results were analyzed after 70% of progression-free survival (PFS) events across 64 centers in China between December 8, 2021, and March 28, 2023. Patients were randomized (2:1) to receive BF or F, with stratification based on visceral involvement (yes/no) and resistance to prior primary or secondary ET. As the primary outcome, PFS was significantly prolonged in the BF group (n = 204) (12.94 months; 95% CI: 11.07–not reached) compared to 7.29 months (95% CI: 5.45–11.04) in the F group (n = 101) (hazard ratio, 0.56; 95% CI: 0.39–0.80; p = 0.001). The objective response rate in the BF group was 39.7% in the intention-to-treat population. Grade ≥3 adverse events were more frequent in the BF group (64.7%) than in the F group (18.8%), with neutropenia, leukopenia, and anemia being the most common. These findings suggest that BF is a promising therapeutic option for patients with HR+/HER2- ABC following ET failure.

Date: 2025
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DOI: 10.1038/s41467-025-58647-z

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