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ACTIVE NOT RECRUITING
NCT02107703
PHASE3

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

Official title: MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

669

Start Date

2014-07-22

Completion Date

2027-12

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DRUG

Abemaciclib

Administered Orally

DRUG

Fulvestrant

Administered IM

DRUG

Placebo

Administered Orally

Locations (146)

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

University of California - San Diego

La Jolla, California, United States

Kaiser Permanente

Riverside, California, United States

Univ of California San Francisco

San Francisco, California, United States

Stanford University Clinic

Stanford, California, United States

Palm Beach Cancer Institue

Atlantis, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Florida Cancer Specialists - South

Fort Myers, Florida, United States

Palm Beach Cancer Institue

Palm Beach Gardens, Florida, United States

Florida Cancer Specialists - North

St. Petersburg, Florida, United States

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, United States

Palm Beach Cancer Institue

Wellington, Florida, United States

Palm Beach Cancer Institue

West Palm Beach, Florida, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

Harbin Clinic

Rome, Georgia, United States

Quincy Medical Group

Quincy, Illinois, United States

Pharmasite Research, Inc.

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Breslin Cancer Center

Lansing, Michigan, United States

Minnesota Oncology/Hematology PA

Minneapolis, Minnesota, United States

Washington University Medical School

City of Saint Peters, Missouri, United States

Washington University Medical School

Creve Coeur, Missouri, United States

Freeman Cancer Institute

Joplin, Missouri, United States

St Lukes Hospital

Kansas City, Missouri, United States

Washington University Medical School

St Louis, Missouri, United States

Washington University Medical School

St Louis, Missouri, United States

Billings Clinic

Billings, Montana, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

Rochester General Hospital

Rochester, New York, United States

Novant Health, Oncology Research Institute

Winston-Salem, North Carolina, United States

Oklahoma Cancer Specialists & Research Institute, LLC

Tulsa, Oklahoma, United States

Sanford Research/USD

Sioux Falls, South Dakota, United States

The Boston Baskin Cancer Group

Memphis, Tennessee, United States

SMO Sarah Cannon Research Inst.

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Oncology Consultants P.A.

Houston, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

St Mary Regional Cancer Center

Walla Walla, Washington, United States

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Monash Cancer Centre

East Bentleigh, Victoria, Australia

St. John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Antwerp University Hospital

Edegem, Antwerpen, Belgium

UZ Brussel

Brussels, Bruxelles-Capitale, Région de, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

Tom Baker Cancer Center

Calgary, Alberta, Canada

London Regional Cancer Program

London, Ontario, Canada

Humber River Hospital

Toronto, Ontario, Canada

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada

Herlev and Gentofte Hospital

Copenhagen, Capital Region, Denmark

Aalborg Universitets hospital

Aalborg, Denmark

Roskilde Sygehus

Roskilde, Denmark

Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, Finland

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

Helsinki, Uusimaa, Finland

Turun Yliopistollinen Keskussairaala

Turku, Finland

CHU Besançon

Besançon, Doubs, France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Clermont-Ferrand, Puy-de-Dôme, France

Polyclinique De Blois

La Chaussée-Saint-Victor, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, France

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Gemeinschaftspraxis hop-augsburg

Augsburg, Bavaria, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bavaria, Germany

Facharztzentrum Eppendorf

Hamburg, Germany

University Hospital of Patras

Pátrai, Achaḯa, Greece

Agios Savvas Regional Cancer Hospital

Athens, Attikí, Greece

University General Hospital of Heraklion

Heraklion, Krítí, Greece

Chania General Hospital 'Agios Georgios'

Chania, Greece

Azienda Ospedaliero Universitaria S.Anna

Cona, Emilia-Romagna, Italy

Istituto Nazionale Tumori Regina Elena

Rome, Roma, Italy

Ospedale Bellaria - Azienda USL di Bologna

Bologna, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Chiba cancer center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Kurume General Hospital

Kurume, Fukuoka, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Saitama Prefectural Cancer Center

Ina-machi, Saitama, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Sagara Hospital

Kagoshima, Japan

Kyoto University Hospital

Kyoto, Japan

National Hospital Organization Osaka Medical Center

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

Hospital Angeles

Tijuana, Estado de Baja California, Mexico

Preparaciones Oncológicas S.C.

León, Guanajuato, Mexico

And 46 more locations on ClinicalTrials.gov