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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

2025-10-21

Healthy Volunteers

Conditions

Breast Neoplasms

Interventions

DRUG

Abemaciclib

Administered Orally

DRUG

Fulvestrant

Administered IM

DRUG

Placebo

Administered Orally

Inclusion Criteria * Have a diagnosis of HR+, HER2- breast cancer * Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria: * relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression * relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression * relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease * presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease * for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting * Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin * Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist * Have either measurable disease or nonmeasurable bone only disease * Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale * Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy Exclusion Criteria * Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study * Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease * Have clinical evidence or history of central nervous system metastasis * Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy * Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively * Have received recent (within 28 days prior to randomization) yellow fever vaccination * Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s) * Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest * Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years * Have received an autologous or allogeneic stem-cell transplant * Have active bacterial or fungal infection, or detectable viral infection * Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents \<7 days prior to randomization

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

Centro Oncológico Internacional (COI)

Guadalajara, Jalisco, Mexico

Grupo Medico Camino Sc

Mexico City, Mexico City, Mexico

Instituto Nacional de Cancerologia

Mexico City, Mexico City, Mexico

OCA Hospital

Monterrey, Nuevo León, Mexico

Tecnologico de Monterrey

Monterrey, Nuevo León, Mexico

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej

Bialystok, Poland

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, Poland

Puerto Rico Hematology/Oncology Group

Bayamón, PR, Puerto Rico

S.C. MedisProf SRL

Cluj-Napoca, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Ianuli Med Consult SRL

Bucharest, Romania

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, Arkhangelskaya oblast, Russia

Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary'

Ivanovo, Ivanovo Oblast, Russia

Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

Moscow, Moscow, Russia

Kursk Regional Oncology Dispensary

Kursk, Russian Federation, Russia

N.N.Petrov Research Institute of Oncology

Saint Petersburg, Sankt-Peterburg, Russia

Saint-Petersburg City Clinical Oncology Dispensary

Saint Petersburg, Sankt-Peterburg, Russia

Chungbuk National University Hospital

Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], South Korea

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Seoul National University Hospital