Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
Summary
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
Timeline
- Start
- 2022-03-11
- Primary completion
- 2024-02-08
- Completion
- 2027-12
Outcome
Met primary endpoint
registry Arm A: Abemaciclib Plus Fulvestrant vs Arm B: Placebo Plus Fulvestrant; p = 0.02; Hazard Ratio (HR) 0.73 (95% CI 0.57 to 0.95) NCT05169567 ↗
paper At the primary analysis (258 events), the hazard ratio (HR) was 0.73 (95% CI, 0.57 to 0.95; nominal P = .017), with median PFS 6.0 PMID 39693591 ↗
Publications
- Zapatero-Solana E, Ding Y, Pulliam N, de Dios A, Ortiz-Ruiz MJ, Lallena MJ. Models of Early Resistance to CDK4/6 Inhibitors Unveil Potential Therapeutic Treatment Sequencing. Int J Mol Sci. 2025 Mar 14;26(6):2643. doi: 10.3390/ijms26062643.
- Kalinsky K, Bianchini G, Hamilton E, Graff SL, Park KH, Jeselsohn R, Demirci U, Martin M, Layman RM, Hurvitz SA, Sammons S, Kaufman PA, Munoz M, Lai JI, Knoderer H, Sandoval C, Chawla AR, Nguyen B, Zhou Y, Ravenberg E, Litchfield LM, Smyth L, Wander SA. Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial. J Clin Oncol. 2025 Mar 20;43(9):1101-1112. doi: 10.1200/JCO-24-02086. Epub 2024 Dec 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Background | Fulvestrant | Small molecule | 500 mg | Intramuscular |