A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Phase 2 Active not recruiting 234 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

Timeline

Start: 2016-09-14
Primary completion: 2018-06-15
Completion: 2026-12

Publications

Hamilton E, Cortes J, Ozyilkan O, Chen SC, Petrakova K, Manikhas A, Jerusalem G, Hegg R, Huober J, Zhang W, Chen Y, Martin M. nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer. Breast Cancer Res Treat. 2022 Aug;195(1):55-64. doi: 10.1007/s10549-022-06662-9. Epub 2022 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abemaciclib	Small molecule	150 mg	Oral
Subject	Abemaciclib	Small molecule	200 mg	Oral
Subject	Tamoxifen	Small molecule	20 mg	Oral
Background	Loperamide	Small molecule	—	Oral

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Summary

Timeline

Publications

Drugs

Indications