Loading
Palbociclib / Letrozole / Abemaciclib · Phase 3 Trial
ClinicalTrials.gov · August 19, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 registration for a planned head-to-head trial comparing a novel agent (BGB-43395) combined with letrozole against standard-of-care CDK4/6 inhibitor plus letrozole in treatment-naïve advanced HR+/HER2− breast cancer. No results have been posted to the registry; the trial is actively recruiting and outcome data are not yet available for clinical interpretation.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. HR+/HER2- Breast Cancer; age from 18 Years. Intervention: Arm A: BGB-43395 + Letrozole. Compared with: Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole — Active Comparator. n = 1,056. 108 sites across 10 countries.
This is a Phase 3 registration for a planned head-to-head trial comparing a novel agent (BGB-43395) combined with letrozole against standard-of-care CDK4/6 inhibitor plus letrozole in treatment-naïve advanced HR+/HER2− breast cancer. No results have been posted to the registry; the trial is actively recruiting and outcome data are not yet available for clinical interpretation.
Primary endpoint is PFS by blinded central review; final efficacy and safety data are not reported.
The source did not state who this applies to in practice.
This is an active Phase 3 trial registration with no results posted; the study is still recruiting and outcomes are not yet reported.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07492641). This is a study registration, not published results. Lead sponsor: BeOne Medicines. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1056 participants (ESTIMATED). Conditions: HR+/HER2- Breast Cancer. Interventions: DRUG: BGB-43395; DRUG: Letrozole; DRUG: Abemaciclib; DRUG: Palbociclib; DRUG: Ribociclib. Primary outcome measures: Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) , Up to approximately 4 years. Brief summary: The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.