OncRef

Clinical Trial: NCT03155997

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-04-24

Study Overview

Brief 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.

Official Title

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Abemaciclib
  • Drug: Standard Adjuvant Endocrine Therapy

Other Study ID Numbers

  • 16338
  • I3Y-MC-JPCF
  • 2016-004362-26
  • NSABP B-58
  • 2016

Start Date (Actual)

2017-07-12

Primary Completion Date (Actual)

2020-03-16

Study Completion Date (Estimated)

2029-05

Enrollment (Actual)

5637

Study Type

Interventional

Phase

Phase 3