314TiP - monarcHER: A phase 2 randomized open-label study of abemaciclib plus trastuzumab (T) with or without fulvestrant (F) compared to standard-of-care c...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Breast Cancer
Presenter Sara Tolaney
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors S.M. Tolaney1, N. Bourayou2, S. Goel1, T. Forrester3, F. André4
  • 1Breast Oncology Center, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 2Medical Oncology, Eli Lilly and Company, Paris/FR
  • 3Statistics-oncology, Eli Lilly and Company, Indianapolis/US
  • 4Breast Cancer Unit, Department Of Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR



Preclinical data strongly suggest a crosstalk between HER2 signaling and the cyclin D/CDK4 signaling pathway in HER2-positive breast cancer cells. Transgenic mouse models, cell line-based studies, and clinical specimens suggest cyclin D/CDK4 mediate resistance to HER2-directed therapy, and CDK4 & CDK6 inhibitors may re-sensitize resistant tumors to HER2 blockade. Abemaciclib, a selective CDK4 & CDK6 inhibitor, demonstrated durable single-agent activity in women with HR+ advanced breast cancer (ABC) (both HER2+ and HER2-) and an acceptable safety profile (both as a single agent and combined with F or T).

Trial design

monarcHER, is a randomized, 3-arm, open-label Phase 2 study that aims to enroll 225 postmenopausal patients with HR + , HER2+ ABC with prior exposure to ≥2 HER2-directed therapies for ABC and prior exposure to T-DM1 and a taxane in any disease setting. Patients may have received other HER2-directed therapy in any disease setting and must not have received F or any CDK4 & CDK6 inhibitor. The study excludes patients with ECOG PS ≥2; LVEF

Clinical trial identification

EudraCT Number: 2015-003400-24, start date 29 January, 2016 ClinicalTrials.gov Identifier: NCT02675231, start date May, 2016

Legal entity responsible for the study

Eli Lilly and Company


Eli Lilly and Company


S.M. Tolaney: Research funding from Genentech, Exelixis, Pfizer, and Novartis. N. Bourayou, T. Forrester: Employee of Eli Lilly and Company and holds equity in the company. S. Goel: Research funding and honoraria from Eli Lilly and Company. F. André: Research Funding: AstraZeneca (Inst), Eisai (Inst), Novartis (Inst), Pfizer (Inst), Eli Lilly (Inst), Servier (Inst).