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ACTIVE NOT RECRUITING
NCT05169567
PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

368

Start Date

2022-03-11

Completion Date

2027-12

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DRUG

Abemaciclib

Administered orally.

DRUG

Fulvestrant

Administered IM.

DRUG

Placebo

Administered orally.

Locations (138)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Providence Medical Foundation

Fullerton, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

TRIO-US (Translational Research in Oncology-US)

Los Angeles, California, United States

Keck School of Medicine of USC

Los Angeles, California, United States

UCLA Hematology/Oncology - Parkside

Santa Monica, California, United States

Olive View-UCLA Medical Center

Sylmar, California, United States

Torrance Memorial Physician Network / Cancer Care

Torrance, California, United States

PIH Health Hematology Medical Oncology

Whittier, California, United States

Rocky Mountain Cancer Center - Hale Parkway

Denver, Colorado, United States

Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI

Fort Myers, Florida, United States

Millennium Oncology Research Clinic

Hollywood, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

Woodlands Medical Specialists, PA

Pensacola, Florida, United States

Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI

Sarasota, Florida, United States

Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI

West Palm Beach, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Central Georgia Cancer Care

Macon, Georgia, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI

Baton Rouge, Louisiana, United States

Clinical Trials of SWLA

Lake Charles, Louisiana, United States

Central Maine Medical Center

Lewiston, Maine, United States

Mfsmc-Hjwci

Baltimore, Maryland, United States

Maryland Oncology Hematology, P.A. - Clinton

Clinton, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

MGH Northshore Cancer Center

Danvers, Massachusetts, United States

Southcoast Centers for Cancer Care

Fairhaven, Massachusetts, United States

Dana-Farber Cancer Institute - Foxborough

Foxborough, Massachusetts, United States

Dana Farber Cancer Center Merrimack Valley

Methuen, Massachusetts, United States

Dana Farber Cancer Institute

Milford, Massachusetts, United States

Mass General Cancer Center

Newton, Massachusetts, United States

Dana Farber Cancer Institute

South Weymouth, Massachusetts, United States

Reliant Medical Group

Worcester, Massachusetts, United States

St. Vincent Frontier Cancer Center

Billings, Montana, United States

Dana Farber Cancer Center Londonderry

Londonderry, New Hampshire, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Lifespan Cancer Institute

Providence, Rhode Island, United States

Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI

Chattanooga, Tennessee, United States

Sarah Cannon Research Institute/SCRI

Nashville, Tennessee, United States

Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI

Nashville, Tennessee, United States

Texas Oncology - Bedford

Bedford, Texas, United States

Texas Oncology - Denton

Denton, Texas, United States

Texas Oncology, P.A.

El Paso, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology - McKinney

McKinney, Texas, United States

Woodlands Medical Specialists, PA

McKinney, Texas, United States

Woodlands Medical Specialists, PA

Mesquite, Texas, United States

Texas Oncology - Plano East

Plano, Texas, United States

Texas Oncology-Plano West

Plano, Texas, United States

Mays Cancer Center

San Antonio, Texas, United States

US Oncology

The Woodlands, Texas, United States

Texas Oncology - Tyler Cancer Center

Tyler, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Intermountain Healthcare - St. George

St. George, Utah, United States

The University of Vermont Medical Center Inc.

Burlington, Vermont, United States

Shenandoah Oncology, P.C.

Winchester, Virginia, United States

Fundación Cenit Para La Investigación En Neurociencias

CABA, Buenos Aires F.D., Argentina

Fundación Respirar

Buenos Aires, Buenos Air, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

CER San Juan

San Juan, Argentina

Algemeen Ziekenhuis klina

Brasschaat, Antwerpen, Belgium

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

CHU UCL Namur/Site Sainte Elisabeth

Namur, Belgium

Multiscan

Pardubice, Pardubický kraj, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Herlev and Gentofte Hospital

Copenhagen, Capital Region, Denmark

Regionshospitalet Gødstrup

Herning, Central Jutland, Denmark

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, France

CHRU de Brest

Brest, Finistère, France

Hôpital privé du Confluent SAS

Nantes, Loire-Atlantique, France

CHD Vendee

La Roche-sur-Yon, Vendée, France

University Hospital of Patras

Pátrai, Achaḯa, Greece

Alexandra Hospital

Athens, Attikí, Greece

University General Hospital of Heraklion

Heraklion, Irakleío, Greece

Euromedica General Clinic of Thessaloniki

Thessaloniki, Greece

Bacs-Kiskun Megyei Korhaz

Kecskemét, Bács-Kiskun county, Hungary

Petz Aladar Egyetemi Oktato Korhaz

Győr, Győr-Moson-Sopron, Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary

Országos Onkológiai Intézet

Budapest, Hungary

Meir Medical Center

Kfar Saba, Central District, Israel

Rabin Medical Center

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Soroka Medical Center

Beersheba, Southern District, Israel

Sourasky Medical Center

Tel Aviv, Tell Abīb, Israel

Humanitas Istituto Clinico Catanese

Misterbianco, Catania, Italy

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, Italy

P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale

Udine, Friuli Venezia Giulia, Italy

Instituto Tumori Giovanni Paolo II

Bari, Italy

Ospedale Misericordia di Grosseto

Grosseto, Italy

Ospedale San Raffaele

Milan, Italy

ASL Viterbo Ospedale Belcolle

Viterbo, Italy

Centro de Investigacion en Artritis y Osteoporosis SC

Mexicali, Estado de Baja California, Mexico

COI Tijuana - Centro Oncológico Internacional

Tijuana, Estado de Baja California, Mexico

Centro Oncológico Internacional (COI)

Guadalajara, Jalisco, Mexico

Centro Regiomontano de Investigación

Monterrey, Nuevo León, Mexico

Oncologico Potosino, S.C.

San Luis Potosí City, San Luis Potosí, Mexico

Europejskie Centrum Zdrowia - Oddzial Onkologii

Otwock, Masovian Voivodeship, Poland

Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

Opole, Opole Voivodeship, Poland

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Korea University Anam Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Kyungpook National University Chilgok Hospital

Daegu, Taegu-Kwangyǒkshi, South Korea

CHUAC-Hospital Teresa Herrera

A Coruña, A Coruña [La Coruña], Spain

Hospital Universitari Son Espases

Palma, Balears [Baleares], Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [Barcelona], Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Región de, Spain

H.R.U Málaga - Hospital Materno-infantil

Málaga, Málaga, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Universitari Sant Joan de Reus

Reus, Tarragona [Tarragona], Spain

Hospital Universitario Doctor Peset

Valencia, Valenciana, Comunitat, Spain

Hospital Infanta Cristina

Badajoz, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario de Toledo

Toledo, Spain

Karolinska Universitetssjukhuset Solna

Stockholm, Stockholms, Sweden

Universitetssjukhuset Örebro

Örebro, Örebro Län [se-18], Sweden

Chi Mei Medical Center

Tainan, Tainan, Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Taipei Tzu Chi General Hospital

New Taipei City, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Izmir Medical Park Hospital

Cordaleo, İzmir, Turkey (Türkiye)

Necmettin Erbakan Meram Medical Fac.

Meram, Konya, Turkey (Türkiye)

Adana City Hospital

Adana, Turkey (Türkiye)

Ankara Gülhane Eitim ve Aratrma Hastanesi

Ankara, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Dicle Üniversitesi

Diyarbakır, Turkey (Türkiye)

Trakya University

Edirne, Turkey (Türkiye)

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

Malatya, Turkey (Türkiye)