CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 5,637 enrolled
Drug / intervention
Abemaciclib +1 moredrug
Likely dose
Abemaciclib administered orally (specific dose not stated)AI-extracted
Key inclusion· 9
  • ✓Women (regardless of menopausal status) or men ≥18 years of age
  • ✓Confirmed HR+, HER2- early-stage resected invasive breast cancer without distant metastases
  • ✓Definitive surgery of primary breast tumor completed
  • ✓Pathologic lymph node involvement with at least one high-risk feature: ≥4 positive axillary nodes, tumor ≥5 cm, grade 3 (Bloom Richardson ≥8), or Ki-67 ≥20%
Key exclusion· 12
  • ✕Metastatic disease or node-negative disease
  • ✕Inflammatory breast cancer
  • ✕History of previous breast cancer, except ipsilateral DCIS ≥5 years ago or contralateral DCIS at any time
  • ✕History of any other cancer unless in complete remission with no therapy for ≥5 years (except non-melanoma skin cancer or cervical carcinoma in situ)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03155997
NCT03155997Phase 3Active
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted May 16, 2017·Updated Apr 24, 2026

In Brief

A Phase 3 clinical trial evaluating Abemaciclib and Standard Adjuvant Endocrine Therapy for Breast Cancer. Active but no longer recruiting, targeting 5,637 participants across 619 sites in 38 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsNSABP Foundation Inc

Timeline

Phase 3Active
201820192020202120222023202420252026202720282029
First PostedMay 16, 2017
Enrollment StartJul 12, 2017
Primary CompletionMar 16, 2020
Study CompletionMay 1, 2029
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago

Interventions

Abemaciclibdrug

Administered orally.

Standard Adjuvant Endocrine Therapydrug

Administered according to label instructions.