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

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

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-) ad...

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Main Authors: 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, Binghe Xu
Format: Article
Language:English
Published: Nature Portfolio 2025-04-01
Series:Nature Communications
Online Access:https://doi.org/10.1038/s41467-025-58647-z
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Summary: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.
ISSN:2041-1723

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