CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 368 enrolled
Drug / intervention
Abemaciclib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT05169567
NCT05169567Phase 3Active

postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

Eli Lilly and Company·interventional·Posted Dec 27, 2021·Updated Jan 16, 2026

In Brief

A Phase 3 clinical trial evaluating Abemaciclib, Fulvestrant, and 1 other intervention for Breast Neoplasm and Neoplasm Metastasis. Active but no longer recruiting, targeting 368 participants across 138 sites in 17 countries.

Detailed Summary

This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Czechia, Denmark, France, Greece, Hungary, Israel, Italy, Mexico, Poland, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3Active
2022202320242025202620272028
First PostedDec 27, 2021
Enrollment StartMar 11, 2022
Primary CompletionFeb 8, 2024
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.5 years ago

Interventions

Abemaciclibdrug

Administered orally.

Fulvestrantdrug

Administered IM.

Placebodrug

Administered orally.