drugset / Trial / NCT03155997
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Timeline
- Start
- 2017-07-12
- Primary completion
- 2020-03-16
- Completion
- 2029-05
Outcome
Met primary endpoint
paper Abemaciclib plus ET demonstrated superior IDFS versus ET alone (P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93) PMID 32954927 ↗
release “monarchE trial, which met its primary endpoint at the second interim efficacy analysis by showing a statistically significant improvement in IDFS.” lilly.com ↗
release “The monarchE primary outcome data builds on the significance of the results of the interim analysis with a 28.7 percent reduction in the risk of recurrence” lilly.com ↗
Publications
- Johnston S, Martin M, O'Shaughnessy J, Hegg R, Tolaney SM, Guarneri V, Del Mastro L, Campone M, Sohn J, Boyle F, Cortes J, Rugo HS, Goetz MP, Hamilton EP, Huang CS, Senkus E, Cicin I, Testa L, Neven P, Huober J, Shao Z, Wei R, Munoz M, San Antonio B, Shahir A, Rastogi P, Harbeck N. Overall survival with abemaciclib in early breast cancer. Ann Oncol. 2026 Feb;37(2):155-165. doi: 10.1016/j.annonc.2025.10.005. Epub 2025 Oct 17.
- Zhang Q, Shen K, Song CG, Ouyang Q, Liu Z, Liu Q, Feng J, Chiu JWY, Tang J, Jiang Z, Tseng LM, Wang X, Yang L, Qian C, Shao Z. Abemaciclib combined with endocrine therapy as adjuvant treatment for hormone-receptor-positive, HER2-, high-risk early breast cancer: 5-year Chinese population analysis of the phase III randomized monarchE study. Ther Adv Med Oncol. 2024 Oct 23;16:17588359241286775. doi: 10.1177/17588359241286775. eCollection 2024.
- Johnston SRD, Rugo HS, Tolaney SM, Munoz Fernandez M, Wei R, Martin M. Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: a plain language summary of the monarchE study. Future Oncol. 2024;20(28):2037-2048. doi: 10.1080/14796694.2024.2362095. Epub 2024 Jul 18.
- Rastogi P, O'Shaughnessy J, Martin M, Boyle F, Cortes J, Rugo HS, Goetz MP, Hamilton EP, Huang CS, Senkus E, Tryakin A, Cicin I, Testa L, Neven P, Huober J, Shao Z, Wei R, Andre V, Munoz M, San Antonio B, Shahir A, Harbeck N, Johnston S. Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes. J Clin Oncol. 2024 Mar 20;42(9):987-993. doi: 10.1200/JCO.23.01994. Epub 2024 Jan 9.
- Ganfornina Andrades A, Fenix Caballero S, Salguero Olid A, Alegre Del-Rey Emilio J. Abemaciclib as adjuvant treatment for high-risk early breast cancer. Farm Hosp. 2024 Mar-Apr;48(2):75-78. doi: 10.1016/j.farma.2023.08.006. Epub 2023 Sep 19. English, Spanish.
- Johnston SRD, Toi M, O'Shaughnessy J, Rastogi P, Campone M, Neven P, Huang CS, Huober J, Jaliffe GG, Cicin I, Tolaney SM, Goetz MP, Rugo HS, Senkus E, Testa L, Del Mastro L, Shimizu C, Wei R, Shahir A, Munoz M, San Antonio B, Andre V, Harbeck N, Martin M; monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023 Jan;24(1):77-90. doi: 10.1016/S1470-2045(22)00694-5. Epub 2022 Dec 6.
- Toi M, Boyle F, Im YH, Reinisch M, Molthrop D, Jiang Z, Wei R, Sapunar F, Grimes BR, Nabinger SC, Johnston SRD. Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1. Oncologist. 2023 Jan 18;28(1):e77-e81. doi: 10.1093/oncolo/oyac234.
- Martin M, Hegg R, Kim SB, Schenker M, Grecea D, Garcia-Saenz JA, Papazisis K, Ouyang Q, Lacko A, Oksuzoglu B, Reeves J, Okera M, Testa L, Shimizu C, Denduluri N, Adamchuk H, Dakhil S, Wei R, Forrester T, Fernandez MM, Zimmermann A, Headley D, Johnston SRD. Treatment With Adjuvant Abemaciclib Plus Endocrine Therapy in Patients With High-risk Early Breast Cancer Who Received Neoadjuvant Chemotherapy: A Prespecified Analysis of the monarchE Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1190-1194. doi: 10.1001/jamaoncol.2022.1488.
- Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.
- Polewski MD, Nielsen GB, Gu Y, Weaver AT, Gegg G, Tabuena-Frolli S, Cajaiba M, Hanks D, Method M, Press MF, Gottstein C, Gruver AM. A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone. Appl Immunohistochem Mol Morphol. 2022 Apr 1;30(4):237-245. doi: 10.1097/PAI.0000000000001009.
- Rugo HS, O'Shaughnessy J, Boyle F, Toi M, Broom R, Blancas I, Gumus M, Yamashita T, Im YH, Rastogi P, Zagouri F, Song C, Campone M, San Antonio B, Shahir A, Hulstijn M, Brown J, Zimmermann A, Wei R, Johnston SRD, Reinisch M, Tolaney SM; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 Jun;33(6):616-627. doi: 10.1016/j.annonc.2022.03.006. Epub 2022 Mar 23.
- Royce M, Osgood C, Mulkey F, Bloomquist E, Pierce WF, Roy A, Kalavar S, Ghosh S, Philip R, Rizvi F, Mixter BD, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer. J Clin Oncol. 2022 Apr 10;40(11):1155-1162. doi: 10.1200/JCO.21.02742. Epub 2022 Jan 27.
- Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |