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Active, not recruiting Phase 3 Interventional Results available

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

ClinicalTrials.gov ID: NCT05169567

Public ClinicalTrials.gov record NCT05169567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 9:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT05169567
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
368 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 11, 2022 (Actual)
Primary completion
Feb 8, 2024 (Actual)
Completion
Dec 2027 (Estimated)
Last update posted
Oct 6, 2026

2022 – 2027

United States locations

U.S. sites
60
U.S. states
21
U.S. cities
55
Facility City State ZIP Site status
St. Joseph's Hospital and Medical Center Phoenix Arizona 85004 —
Highlands Oncology Group Springdale Arkansas 72762 —
Providence Medical Foundation Fullerton California 92835 —
Cancer and Blood Specialty Clinic Los Alamitos California 90720 —
TRIO-US (Translational Research in Oncology-US) Los Angeles California 90024 —
Keck School of Medicine of USC Los Angeles California 90033 —
UCLA Hematology/Oncology - Parkside Santa Monica California 90404 —
Olive View-UCLA Medical Center Sylmar California 91342 —
Torrance Memorial Physician Network / Cancer Care Torrance California 90505 —
PIH Health Hematology Medical Oncology Whittier California 90602 —
Rocky Mountain Cancer Center - Hale Parkway Denver Colorado 80220 —
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI Fort Myers Florida 33901-8101 —
Millennium Oncology Research Clinic Hollywood Florida 33024 —
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida 33136 —
Woodlands Medical Specialists, PA Pensacola Florida 32503 —
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI Sarasota Florida 34232 —
Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI West Palm Beach Florida 33401 —
Winship Cancer Institute, Emory University Atlanta Georgia 30322 —
Northeast Georgia Medical Center Gainesville Georgia 30501 —
Central Georgia Cancer Care Macon Georgia 31201 —
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 —
Ingalls Memorial Hospital Harvey Illinois 60426 —
Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI Baton Rouge Louisiana 70809 —
Clinical Trials of SWLA Lake Charles Louisiana 70601 —
Central Maine Medical Center Lewiston Maine 04240 —
Mfsmc-Hjwci Baltimore Maryland 21237 —
Maryland Oncology Hematology, P.A. - Clinton Clinton Maryland 20735 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
MGH Northshore Cancer Center Danvers Massachusetts 01923 —
Southcoast Centers for Cancer Care Fairhaven Massachusetts 02719 —
Dana-Farber Cancer Institute - Foxborough Foxborough Massachusetts 02035 —
Dana Farber Cancer Center Merrimack Valley Methuen Massachusetts 01844 —
Dana Farber Cancer Institute Milford Massachusetts 01757 —
Mass General Cancer Center Newton Massachusetts 02462 —
Dana Farber Cancer Institute South Weymouth Massachusetts 02190 —
Reliant Medical Group Worcester Massachusetts 01606 —
St. Vincent Frontier Cancer Center Billings Montana 59102 —
Dana Farber Cancer Center Londonderry Londonderry New Hampshire 03053 —
University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico 87106 —
Lifespan Cancer Institute Providence Rhode Island 02906 —
Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI Chattanooga Tennessee 37404 —
Sarah Cannon Research Institute/SCRI Nashville Tennessee 37203 —
Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI Nashville Tennessee 37203 —
Texas Oncology - Bedford Bedford Texas 76022 —
Texas Oncology - Denton Denton Texas 76201 —
Texas Oncology, P.A. El Paso Texas 79902 —
University of Texas MD Anderson Cancer Center Houston Texas 77030-4009 —
Texas Oncology - McKinney McKinney Texas 75071 —
Woodlands Medical Specialists, PA McKinney Texas 75071 —
Woodlands Medical Specialists, PA Mesquite Texas 75150 —
Texas Oncology - Plano East Plano Texas 75075-7787 —
Texas Oncology-Plano West Plano Texas 75093 —
Mays Cancer Center San Antonio Texas 78229 —
US Oncology The Woodlands Texas 77380 —
Texas Oncology - Tyler Cancer Center Tyler Texas 75702 —
Intermountain Medical Center Murray Utah 84107 —
Intermountain Healthcare - St. George St. George Utah 84790 —
The University of Vermont Medical Center Inc. Burlington Vermont 05401 —
Shenandoah Oncology, P.C. Winchester Virginia 22601 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 78 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05169567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 6, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05169567 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →