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

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.

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Publication Details

Journal
Nature Communications
Published
2025-04-09
DOI
https://doi.org/10.1038/s41467-025-58647-z
Citations
4
Primary Topic
Advanced Breast Cancer Therapies
Type
article
Field-Weighted Citation Impact
6.07
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article

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

Xinhong Wu, Binghe Xu, Biyun Wang, Jingfen Wang et al.
4 citations
Nature Communications
Advanced Breast Cancer Therapies
6.07
article

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

Xinhong Wu, Binghe Xu, Biyun Wang, Jingfen Wang, Zhaofeng Niu, Xianghui Duan, Jiayu Wang, Tao Sun, Yaping Meng, Shu Wang, Li Wang, Huihui Li, Fei Liu, Wei Li, Ning Liu, Huiping Li, Shuya Wang, Hongsheng Li, Qingyuan Zhang, Guohua Yu, Xinshuai Wang, Zhongsheng Tong, Chang Gong, Yuee Teng, Quchang Ouyang
article en
4 citations

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.

Nature CommunicationsVol. 16(1)
Yuncheng University (CN), Harbin Medical University (CN), Sun Yat-sen University (CN), Henan University of Science and Technology (CN), Shanxi Medical University (CN), Jilin University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Tianjin Medical University Cancer Institute and Hospital (CN), National Cancer Center (US), Fudan University Shanghai Cancer Center (CN), Peking University Cancer Hospital (CN), Sun Yat-sen Memorial Hospital (CN), Linyi People's Hospital (CN), Beijing Biocytogen (China) (CN), Shandong Tumor Hospital (CN), Third Affiliated Hospital of Harbin Medical University (CN), Weifang People's Hospital (CN), Hunan Cancer Hospital (CN), Peking University People's Hospital (CN), First Hospital of Jilin University (CN), First Hospital of China Medical University (CN), Hubei Cancer Hospital (CN), Liaoning Cancer Hospital & Institute (CN), Shandong First Medical University (CN), Yuncheng Central Hospital, Huazhong University of Science and Technology (CN), China Medical University (CN), Guangzhou Medical University (CN)
Gender equality
Openalex Percentile: Top 4%
Advanced Breast Cancer Therapies
6.07
DOIOpen Access PDFOpenAlex
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