A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

Summary

The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.

Timeline

Start

2016-12-05

Primary completion

2019-03-29

Completion

2028-03

Outcome

Met primary endpoint

registry Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) vs Placebo + NSAI; p = 0.0001; Hazard Ratio (HR) 0.499 (95% CI 0.346 to 0.719); Log Rank NCT02763566 ↗

paper Abemaciclib significantly improved PFS versus placebo (median: not reached versus 14.7 months; hazard ratio 0.499; 95% confidence intervals (CI) 0.346-0.719; p = 0.0001). PMID 33149768 ↗

Publications

• Hu X, Zhang Q, Sun T, Yin Y, Li H, Yan M, Tong Z, Li M, Teng Y, Oppermann CP, Kanakasetty GB, Portugal MC, Yang L, Zhang W, Jiang Z. Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2- advanced breast cancer: Final results of the randomized phase III MONARCH plus trial. Chin Med J (Engl). 2025 Jun 20;138(12):1477-1486. doi: 10.1097/CM9.0000000000003151. Epub 2024 Oct 10.
• Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, Oppermann CP, Liu YP, Costa R, Li M, Cheng Y, Ouyang QC, Chen X, Liao N, Wu XH, Wang XJ, Feng JF, Hegg R, Kanakasetty GB, Coccia-Portugal MA, Han RB, Lu Y, Chi HD, Jiang ZF, Hu XC. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 Oct 22;12:1758835920963925. doi: 10.1177/1758835920963925. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abemaciclib	Small molecule	150 mg	Oral
Background	Anastrozole	Other / unclassified	1 mg	Oral
Background	Fulvestrant	Small molecule	500 mg	Intramuscular
Background	Letrozole	Other / unclassified	2.5 mg	Oral

Indications