Trials / Active Not Recruiting
Active Not RecruitingNCT05169567
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 368 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abemaciclib | Administered orally. |
| DRUG | Fulvestrant | Administered IM. |
| DRUG | Placebo | Administered orally. |
Timeline
- Start date
- 2022-03-11
- Primary completion
- 2024-02-08
- Completion
- 2027-12-01
- First posted
- 2021-12-27
- Last updated
- 2026-01-16
- Results posted
- 2025-02-27
Locations
138 sites across 17 countries: United States, Argentina, Belgium, Czechia, Denmark, France, Greece, Hungary, Israel, Italy, Mexico, Poland, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05169567. Inclusion in this directory is not an endorsement.