Trial reportNature communications2025
Bireociclib plus fulvestrant for HR+/HER2- advanced female breast cancer progressed on or after endocrine therapy: phase 3 BRIGHT-2 study interim analysis.
Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05077449 (A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- CDK4/6 inhibitors combined with fulvestrant for the treatment of HR+/HER2-advanced or metastatic breast cancer: a Bayesian network meta-analysis.BMC cancer · 2026Pooled it
- Efficacy and Mechanisms of CDK4/6 Inhibitors in Breast Cancer: Advancing Targeted Therapeutic Strategies.Oncology research · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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