Bireociclib Plus Fulvestrant in Advanced Breast Cancer After Endocrine Progression: The BRIGHT-2 Phase 3 Randomized Clinical Trial - PubMed
a month ago
- #breast cancer
- #clinical trial
- #endocrine therapy
- The BRIGHT-2 trial evaluated bireociclib plus fulvestrant in HR-positive, ERBB2-negative advanced breast cancer (ABC) after endocrine therapy progression.
- This phase 3 randomized clinical trial involved 305 patients, with a 2:1 randomization to bireociclib plus fulvestrant (204 patients) or placebo plus fulvestrant (101 patients).
- Bireociclib plus fulvestrant significantly improved progression-free survival (PFS) compared to placebo (median PFS 14.7 months vs. 7.3 months; HR 0.54, P < .001).
- The objective response rate was higher in the bireociclib group (45.6% vs. 14.9%) with a prolonged median duration of response.
- Safety profiles were consistent with known cyclin-dependent kinase 4/6 inhibitors, and subgroup analyses showed consistent PFS benefits across various patient characteristics.
- Patients with early-onset diarrhea appeared to derive more benefit from bireociclib (HR 0.49).
- The study confirms bireociclib plus fulvestrant as a viable treatment option for HR-positive, ERBB2-negative ABC with manageable safety.